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.
SUMMARYThe 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 ProcessOnce 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.
#LI-DNP
