Location: United States
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Senior/
Principal Statistician
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
SUMMARY
The contractor will provide statistical expertise and operational support for oncology clinical trial projects, with responsibility for ensuring the accuracy, quality, and reproducibility of statistical deliverables. The role requires strong oncology clinical trial experience, working knowledge of CDISC standards, and the ability to collaborate effectively with internal study teams and relevant functional partners, as applicable.
Key Responsibilities
Support statistical analyses of oncology endpoints, including time-to-event and response-based endpoints.
Perform event projections to estimate the timing of planned event-driven analyses.
Review and provide feedback on SDTM and ADaM specifications, tables, listings, figures, statistical analysis plans, protocol amendments, and relevant study documentation.
Conduct routine study data review to identify inconsistencies, missing data, or other issues that may affect analysis or interpretation.
Validate statistical outputs and provide documentation supporting reproducibility and quality control.
Required Skills and Experience
Demonstrated experience supporting Phase 2 and Phase 3 oncology clinical trials, including event-driven and response-based endpoints.
Experience reviewing clinical trial data to identify inconsistencies, missing data, unexpected patterns, or issues requiring follow-up.
Ability to document review findings, assumptions, queries, and follow-up items clearly and track issues through resolution.
Working knowledge of CDISC standards, including SDTM and ADaM.
Strong written communication skills, including the ability to summarize findings, recommendations, and data issues for study team review.
Strong analytical skills and a methodical approach to data review, statistical output review, and issue identification.
Ability to collaborate with study teams, programming teams, and relevant functional partners to support timely resolution of data and analysis-related questions.
Solid understanding of statistical analysis methodology and principles of experimental design.
Proficiency with statistical programming and data processing software, such as SAS and/or R.
Education
PhD or equivalent degree in statistics, biostatistics, or a related discipline with at least 3 years of relevant work experience; or Master’s degree with at least 6 years of relevant work experience.
Work Expectations
The contractor is expected to be available during core U.S. business hours, generally 9:00 a.m.–3:00 p.m. Eastern Time, to interact with U.S.-based study teams.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-DNP
Location: United Kingdom
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking an experienced
Senior/Principal Statistician
Consultant
to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development.
Key Responsibilities
Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials.
Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies.
Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation.
Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance.
Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA.
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams.
Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans.
Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges.
Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents.
Identify statistical risks and recommend appropriate solutions throughout the clinical development process.
Provide technical guidance and mentorship to statisticians and other team members, as appropriate.
Required Qualifications and Experience
PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered.
Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
Strong knowledge of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis methodologies.
Proven experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.
Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses.
Experience supporting clinical development programs in
oncology, rare diseases, and/or neuroscience.
Experience supporting regulatory submissions and health authority interactions.
Experience with complex clinical trial designs and advanced statistical methodologies.
Proficiency in statistical programming tools such as SAS and/or R.
Strong analytical, problem-solving, communication, and stakeholder-management skills.
Ability to work independently and collaborate effectively with global cross-functional teams.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #contract
Location: European Union
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking an experienced
Senior/Principal Statistician
Consultant
to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development.
Key Responsibilities
Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials.
Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies.
Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation.
Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance.
Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA.
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams.
Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans.
Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges.
Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents.
Identify statistical risks and recommend appropriate solutions throughout the clinical development process.
Provide technical guidance and mentorship to statisticians and other team members, as appropriate.
Required Qualifications and Experience
PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered.
Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
Strong knowledge of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis methodologies.
Proven experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.
Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses.
Experience supporting clinical development programs in
oncology, rare diseases, and/or neuroscience.
Experience supporting regulatory submissions and health authority interactions.
Experience with complex clinical trial designs and advanced statistical methodologies.
Proficiency in statistical programming tools such as SAS and/or R.
Strong analytical, problem-solving, communication, and stakeholder-management skills.
Ability to work independently and collaborate effectively with global cross-functional teams.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #contract
Location: United Kingdom
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Principal Statistician
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking a highly skilled
Principal Statistician
to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Key Responsibilities
Lead and provide statistical support for clinical studies.
Act as the
lead statistician
on assigned studies, overseeing statistical strategy and deliverables
Author and review key statistical documents, including:
Statistical Analysis Plans (SAPs)
Analysis Database Specifications (ADS)
Statistical sections of clinical study reports
Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
Provide guidance and oversight to statistical programmers as needed
Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
Required Qualifications
MS or PhD in Statistics, Biostatistics, or a related field
There are no specific therapeutic area requirements; however, experience in Oncology, Rare Disease, or Neuroscience would be advantageous.
Strong oral and written communication skills, with the ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Permanent
Location: United Kingdom
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Senior Statistician
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking a highly skilled
Senior Statistician
to to join our biometrics team. This is a full-time permanent opportunity with
REMOTE.
.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Job Responsibilities
Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Responsible for assuring that data for statistical analyses are complete, accurate, and consistent.
Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
Responsible for the validity of the analysis and exploring alternative analysis strategies as needed.
Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
Responsible for the statistical methods section of the reports. Identifies and corrects common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and ensures project-wide consistency.
Effectively mentor peers with regard to statistical methodology and provide appropriate training to less experienced statisticians.
Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.
Requirements:
MS or PhD in Statistics, Biostatistics, or related field. PhD with 3-4 years of experience or MS with 5-7 years of experience.
There are no specific therapeutic area requirements; however, experience in Oncology, Rare Disease, or Neuroscience would be advantageous.
Strong oral and written communication skills, with the ability to effectively communicate internally and with clients.
Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA.
The Application Process
Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry-average turnover rates.
ClinChoice is an equal-opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #Senior#permanent
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Senior Statistical Programmer Consultant
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
The
Senior Statistical Programmer Consultant
is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks
Key Responsibilities:
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
Programs independently with high efficiency and quality.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
Ensures compliance with standards and automation usage.
Plans and support team activities and tasks.
Communicates and escalates risks within the assigned studies and/or projects.
Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.
Education and Experience:
Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical and regulatory requirements relevant for the role
Ability to proactively manage concurrent activities within a project
Proficient ability to influence relevant stakeholders on programming-related items
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #senior#contract
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Senior Statistical Programmer Consultant
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
We are seeking an experienced
Senior Statistical Programmer
with strong expertise in clinical trial programming and a solid background in
oncology
. The successful candidate will be capable of independently leading statistical programming activities across clinical studies, partnering closely with statisticians, clinical teams, and other cross-functional stakeholders.
This role requires strong technical expertise in
SAS programming, CDISC standards, and clinical trial reporting
, along with the ability to take ownership of programming deliverables and provide guidance to junior team members.
Key Responsibilities
Lead statistical programming activities for clinical studies within the
oncology therapeutic area
, from study start-up through database lock, analysis, and reporting.
Develop, review, and maintain high-quality SAS programs for
SDTM, ADaM, Tables, Listings, and Figures (TLFs)
.
Lead programming activities for interim and final analyses, including complex efficacy and safety analyses.
Work closely with Biostatisticians to understand statistical analysis plans, programming specifications, and study requirements.
Develop and review programming specifications and ensure consistency with study protocols, SAPs, and statistical methodology.
Support the creation and validation of
CDISC-compliant SDTM and ADaM datasets
.
Generate and validate TLFs for clinical study reports, regulatory submissions, and other clinical deliverables.
Perform independent programming validation and quality control of statistical outputs and datasets.
Support submission-related activities and respond to programming and data-related queries from cross-functional and regulatory teams.
Identify potential programming issues and proactively communicate risks, timelines, and solutions to project stakeholders.
Coordinate programming activities across studies and ensure deliverables are completed within agreed timelines and quality standards.
Provide technical guidance and mentorship to Statistical Programmers and other programming team members.
Participate in client/project meetings and effectively communicate technical information to both technical and non-technical stakeholders.
Required Qualifications
Bachelor's or Master's degree in
Statistics, Biostatistics, Mathematics, Computer Science, or a related field
.
Strong experience in
clinical trial statistical programming
, preferably within a CRO, pharmaceutical, or biotechnology environment.
Significant experience working on
oncology clinical trials
.
Basic or working knowledge of R programming is preferred.
Experience supporting regulatory submissions
Strong proficiency in
SAS programming
, including Base SAS and relevant SAS procedures used for clinical trial reporting.
Strong knowledge of
CDISC standards
, particularly SDTM and ADaM.
Experience developing and validating
TLFs
for clinical trials.
Experience working with complex clinical trial data and supporting statistical analyses.
Ability to independently manage programming deliverables and lead study-level programming activities.
Strong understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports.
Excellent communication, organizational, problem-solving, and collaboration skills.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #senior#contract
Location: United Kingdom
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
We are building our talent pipeline for 2027 and expect to have multiple opportunities throughout the year for experienced professionals in Clinical Statistical Programming at the Senior and Principal level. We anticipate hiring for up to 20 positions during calendar year 2027, with openings becoming available at different times based on client demand and business growth.
The
Senior/Principal Statistical Programmer
is responsible for serving as a technical and study programming lead across multiple compounds and/or studies within the Statistical Programming function, supporting Ipsen’s assets within a specific therapeutic area such as
Oncology, Rare Disease, or Neuroscience
.
The role requires strong hands-on statistical programming expertise, study leadership, and technical knowledge to ensure the quality, consistency, and timely delivery of statistical programming activities. The programmer will work closely with statisticians, clinical teams, data management, and other cross-functional stakeholders and may also provide technical oversight of outsourced programming activities.
Main Responsibilities & Technical Competencies
Serve as a
lead statistical programmer
for multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities.
Lead and execute statistical programming activities across clinical trials, from study start-up through database lock, reporting, and regulatory submission.
Ensure consistency, quality, and executional excellence across programming deliverables for assigned studies.
Support programming activities for
global regulatory submissions
and responses to health authority questions.
Provide technical oversight and guidance for outsourced statistical programming activities, ensuring deliverables meet required quality, budget, and timeline expectations.
Develop, review, and validate high-quality statistical programming deliverables, including
tables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML
.
Provide technical expertise in
SAS programming
, including development, QC/validation, and documentation of statistical programs.
Contribute to the development, implementation, and continuous improvement of
SAS programming standards, SOPs, work instructions, and best practices
.
Ensure study-related programming documentation is maintained in accordance with Ipsen processes and is inspection/audit ready.
Collaborate with statisticians and cross-functional teams to understand complex study designs, endpoints, and analysis requirements and translate them into robust programming solutions.
Provide
technical guidance and mentoring to other statistical programmers
and contribute to the development of programming capabilities within the organization.
Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies.
Act as a
subject matter expert
in statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas.
Behavioural Competencies Required
Collaborates effectively across functions and organizational boundaries.
Communicates clearly with both technical and non-technical stakeholders.
Proactively seeks relevant stakeholder input and expertise to support effective decision-making.
Takes ownership and accountability for decisions, actions, successes, and challenges.
Demonstrates strong planning and organizational skills, effectively managing priorities, resources, and timelines.
Maintains a strong focus on quality, compliance, and timely execution.
Demonstrates a proactive approach to identifying risks, resolving issues, and driving continuous improvement.
Supports and coaches colleagues by sharing technical knowledge and best practices.
Knowledge & Experience
Strong proficiency in
SAS programming
within a pharmaceutical, biotechnology, or CRO environment.
Strong understanding of
CDISC standards
, including SDTM and ADaM.
Hands-on experience with
SDTM and ADaM specification, development, and programming
.
Strong experience in
TFL programming and reporting
.
Experience supporting clinical trial reporting and/or regulatory submissions.
Experience working with complex clinical trial data and study designs.
Ability to provide technical leadership and independently manage programming activities across multiple studies.
8+ years of statistical programming experience
in a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
Experience in one or more of the following therapeutic areas is preferred:
Oncology, Rare Disease, or Neuroscience
.
Knowledge & Experience (preferred)
R or other packages are desired;
Understand clinical data flow. Experience in NDA/sNDA submission is desired.
Education / Certifications (essential)
Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline
Language(s) (essential)
English
Language(s) (preferred)
French
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Contract
Location: European Union
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
We are building our talent pipeline for 2027 and expect to have multiple opportunities throughout the year for experienced professionals in Clinical Statistical Programming at the Senior and Principal level. We anticipate hiring for up to 20 positions during calendar year 2027, with openings becoming available at different times based on client demand and business growth.
The
Senior/Principal Statistical Programmer
is responsible for serving as a technical and study programming lead across multiple compounds and/or studies within the Statistical Programming function, supporting Ipsen’s assets within a specific therapeutic area such as
Oncology, Rare Disease, or Neuroscience
.
The role requires strong hands-on statistical programming expertise, study leadership, and technical knowledge to ensure the quality, consistency, and timely delivery of statistical programming activities. The programmer will work closely with statisticians, clinical teams, data management, and other cross-functional stakeholders and may also provide technical oversight of outsourced programming activities.
Main Responsibilities & Technical Competencies
Serve as a
lead statistical programmer
for multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities.
Lead and execute statistical programming activities across clinical trials, from study start-up through database lock, reporting, and regulatory submission.
Ensure consistency, quality, and executional excellence across programming deliverables for assigned studies.
Support programming activities for
global regulatory submissions
and responses to health authority questions.
Provide technical oversight and guidance for outsourced statistical programming activities, ensuring deliverables meet required quality, budget, and timeline expectations.
Develop, review, and validate high-quality statistical programming deliverables, including
tables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML
.
Provide technical expertise in
SAS programming
, including development, QC/validation, and documentation of statistical programs.
Contribute to the development, implementation, and continuous improvement of
SAS programming standards, SOPs, work instructions, and best practices
.
Ensure study-related programming documentation is maintained in accordance with Ipsen processes and is inspection/audit ready.
Collaborate with statisticians and cross-functional teams to understand complex study designs, endpoints, and analysis requirements and translate them into robust programming solutions.
Provide
technical guidance and mentoring to other statistical programmers
and contribute to the development of programming capabilities within the organization.
Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies.
Act as a
subject matter expert
in statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas.
Behavioural Competencies Required
Collaborates effectively across functions and organizational boundaries.
Communicates clearly with both technical and non-technical stakeholders.
Proactively seeks relevant stakeholder input and expertise to support effective decision-making.
Takes ownership and accountability for decisions, actions, successes, and challenges.
Demonstrates strong planning and organizational skills, effectively managing priorities, resources, and timelines.
Maintains a strong focus on quality, compliance, and timely execution.
Demonstrates a proactive approach to identifying risks, resolving issues, and driving continuous improvement.
Supports and coaches colleagues by sharing technical knowledge and best practices.
Knowledge & Experience
Strong proficiency in
SAS programming
within a pharmaceutical, biotechnology, or CRO environment.
Strong understanding of
CDISC standards
, including SDTM and ADaM.
Hands-on experience with
SDTM and ADaM specification, development, and programming
.
Strong experience in
TFL programming and reporting
.
Experience supporting clinical trial reporting and/or regulatory submissions.
Experience working with complex clinical trial data and study designs.
Ability to provide technical leadership and independently manage programming activities across multiple studies.
8+ years of statistical programming experience
in a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
Experience in one or more of the following therapeutic areas is preferred:
Oncology, Rare Disease, or Neuroscience
.
Knowledge & Experience (preferred)
R or other packages are desired;
Understand clinical data flow. Experience in NDA/sNDA submission is desired.
Education / Certifications (essential)
Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline
Language(s) (essential)
English
Language(s) (preferred)
French
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Contract
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Senior Statistical Programmer Consultant
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
The
Senior Statistical Programmer Consultant
is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks
Key Responsibilities:
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
Programs independently with high efficiency and quality.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
Ensures compliance with standards and automation usage.
Plans and support team activities and tasks.
Communicates and escalates risks within the assigned studies and/or projects.
Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.
Education and Experience:
Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical and regulatory requirements relevant for the role
Ability to proactively manage concurrent activities within a project
Proficient ability to influence relevant stakeholders on programming-related items
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #senior#contract
Location: United States
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Principal Statistician
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking a highly skilled
Principal Statistician
to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Key Responsibilities
Lead and provide statistical support for clinical studies, primarily within
Oncology
Act as the
lead statistician
on assigned studies, overseeing statistical strategy and deliverables
Author and review key statistical documents, including:
Statistical Analysis Plans (SAPs)
Analysis Database Specifications (ADS)
Statistical sections of clinical study reports
Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
Provide guidance and oversight to statistical programmers as needed
Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
Required Qualifications
MS or PhD in Statistics, Biostatistics, or a related field
Strong experience in Oncology studies
Hands-on experience writing:
Statistical Analysis Plans (SAPs)
Analysis Database Specifications
Reviewing and interpreting analysis results
SAS programming skills required
(hands-on or strong working knowledge)
Excellent
written and verbal communication skills
Experience working in a CRO and/or pharmaceutical/biotech environment
Preferred Qualifications
Experience leading Phase II–III clinical trials
Prior interaction with regulatory agencies
Experience mentoring junior statisticians or programmers
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Permanent
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Senior Real World Data Programmer Consultant
to join one of our clients.
ClinChoice is a leading global CRO, dedicated to supporting clinical trials and real-world evidence research with a focus on exceptional quality, career development, and a supportive culture. As we expand our presence and offerings, we’re looking for an experienced Senior Real World Data Analytics Consultant to join our dynamic team and lead analytical efforts across diverse therapeutic areas for a high-profile sponsor.
Position Overview:
We are seeking a
Senior Real World Data (RWD) Analytics Consultant/Senior Real World Data Programmer Consultant
to lead and oversee complex statistical analyses, provide high-level strategic recommendations, and guide junior analysts in the execution of observational research. This leadership position combines technical expertise with client-facing responsibilities, allowing the successful candidate to influence key decisions within our client’s RWE and cross-functional teams. The Senior Consultant will be responsible for ensuring the highest standards of data analysis and driving innovations that enhance our client’s research outcomes.
Key Responsibilities:
Lead the development and execution of statistical analysis plans (SAPs) for large-scale real-world evidence (RWE) studies. Work directly with cross-functional teams and senior stakeholders to design data-driven solutions that meet sponsor needs.
Oversee and mentor junior analysts, reviewing work for accuracy, quality, and consistency. Provide guidance on the development and optimization of RWD analytics workflows.
Establish and maintain strong, trusted relationships with client counterparts. Act as a key advisor, offering strategic insights based on data findings, and helping guide decision-making processes.
Lead the development of new tools and automated workflows to improve the efficiency and impact of RWD analysis. Drive the use of advanced analytics and machine learning to derive actionable insights from large, complex datasets.
Lead the creation of sophisticated data visualizations, dashboards, and other reporting tools. Ensure that findings are effectively communicated to both technical and non-technical stakeholders.
Drive the continuous improvement of data management, analysis methodologies, and reporting standards. Actively contribute to the development of best practices and standard operating procedures.
Collaborate with internal teams (data scientists, epidemiologists, statisticians) and external stakeholders to integrate data from multiple sources and design innovative solutions.
Qualifications:
Experience:
Minimum 4-5 years of experience in RWD analytics, biostatistics, epidemiology, or a related field, with at least 3 years in a leadership or consultancy role.
Proven track record in managing complex observational research projects in the life sciences or healthcare sector, particularly with large health databases (claims data, EMR, etc.).
Technical Skills:
Expertise in SAS programming; advanced proficiency in SQL, R, Python, and other relevant programming languages (e.g., MATLAB, Hadoop, Spark).
Experience working with cloud platforms like AWS, Azure, or Google Cloud is strongly preferred.
Expertise in advanced data visualization tools such as Tableau, Power BI, or D3.js.
Knowledge & Expertise:
Deep understanding of the US healthcare system, health insurance claims data, and electronic medical records (EMR).
Experience applying advanced statistical methods and machine learning techniques to large healthcare datasets.
Familiarity with database management, data wrangling, and data integration techniques..
Education:
Advanced degree (Master’s or PhD) in Biostatistics, Epidemiology, Data Science, Computer Science, or a related field.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Senior #Contract
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
ClinChoice is searching for a
Clinical R Data Scientist Consultant
to join one of our clients.
We are seeking a
Clinical R Data Scientist Consultant
with strong experience in
R
and a solid background in
clinical programming
. The ideal candidate will have hands-on experience developing
SDTM and ADAM datasets
using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams.
Key Responsibilities
Develop, validate, and maintain
SDTM and ADaM datasets
using
R
following CDISC standards.
Support TLF (Tables, Listings, Figures) generation in R or SAS as needed.
Write efficient, reproducible, and well-structured
R scripts
for clinical data analysis and reporting.
Collaborate with statisticians, data managers, and clinical teams to understand programming requirements.
Perform
QC checks
, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA).
Contribute to programming workflows, documentation, and version control best practices.
Support automation initiatives and R-based pipeline development.
Utilize SAS for legacy studies or where SAS support is required.
Required Qualifications
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
2-3+ years
of experience in
clinical programming
, with a strong focus on R.
Proven experience in creating
SDTM and ADaM datasets
using R.
Working knowledge of
SAS programming
.
Solid understanding of
CDISC standards
(SDTM, ADaM).
Experience with clinical trial data, regulatory submissions, and QC processes.
Strong analytical, problem-solving, and documentation skills.
Required Qualifications
Experience with R packages such as
tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC)
, or other clinical programming toolkits.
Understanding of R Markdown, Shiny apps, or reproducible reporting tools.
Exposure to GxP validation, version control (Git), and automated workflows.
Experience working in a CRO or pharmaceutical environment.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Senior #Contract
Location: United States
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Principal Statistician
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking a highly skilled
Principal Statistician
to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Key Responsibilities
Lead and provide statistical support for clinical studies, primarily within
Immunology or any therapeutic areas
Act as the
lead statistician
on assigned studies, overseeing statistical strategy and deliverables
Author and review key statistical documents, including:
Statistical Analysis Plans (SAPs)
Analysis Database Specifications (ADS)
Statistical sections of clinical study reports
Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
Provide guidance and oversight to statistical programmers as needed
Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
Required Qualifications
MS or PhD in Statistics, Biostatistics, or a related field
Strong experience in Oncology studies
Hands-on experience writing:
Statistical Analysis Plans (SAPs)
Analysis Database Specifications
Reviewing and interpreting analysis results
SAS programming skills required
(hands-on or strong working knowledge)
Excellent
written and verbal communication skills
Experience working in a CRO and/or pharmaceutical/biotech environment
Preferred Qualifications
Experience leading Phase II–III clinical trials
Prior interaction with regulatory agencies
Experience mentoring junior statisticians or programmers
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Permanent
Location: Pasig City, Philippines
Responsibilities:
Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
Develop SDTM specifications and generate SDTM datasets using SAS.
Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
Proficient in analyze information and develop innovative solutions to programming and data analysis challenges;
Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation
Follow and reinforce regulatory agency requirements during daily job.
Serve as a programming team lead and contribute to department initiative.
Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
Review draft and final production deliverables for project to ensure quality and consistency.
Skills and Qualifications:
Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
Minimum of 4+ years of clinical programming experience, along with 1+ year of project management and 1+ year of people management experience.
Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Good understanding of clinical drug development process.
Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
Good understanding of clinical drug development process.
Detail-oriented and ability to learn and adapt to changes.
