Описание вакансии
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.
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