FSP Principal Biostatistician, Safety Analytics
$111,000–$309,000 year
Remote · Durham, North Carolina, United States or Canada
Job Summary
Lead safety analytics statistical leadership for Phase 1-3 clinical trials, focusing on safety endpoints. Responsibilities include ADaM/TFL standard development for safety deliverables (e.g., hypersensitivity, injection/infusion site reactions), delivering Patient Profile displays, performing ADaM/TFL/interactive package reviews, identifying root causes of issues, providing guidance to programmers, collaborating with multi-disciplinary teams on study design and protocol development, and contributing to regulatory documents (CSRs, NDA, DSURs, ISS, ISE). Requires PhD or equivalent in statistics/biostatistics with substantial industry experience and expertise in ADaM, TFLs, CDISC standards, ICH GCP, and SAS/R programming.
Required Qualifications
- PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
- MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
- At least 2 years of Phase 1, 2 and 3 clinical trial experience.
- Strong experience reviewing ADaM datasets and TFLs (standard and customized output review).
- Ability to follow data specifications and programming specifications and provide clear, actionable review comments.
- Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors.
- Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward.
- R/SAS programming skills
- Demonstrated ability to work pro-actively and independently.
- Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
- Experience with CDISC, including SDTM, ADAM, CDASH
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