Описание вакансии
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.
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