Simulstat
Principal Biostatistician
Remote, California
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Remote, 6-month renewable contract
The Principal Biostatistician will lead Biostatistics planning activities and deliverables in support of core clinical development programs and use a combination of curiosity and statistical acumen to identify and solve interesting problems.
Responsibilities
- Devise and lead statistical strategies for clinical development of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
- Accountable for accuracy and statistical integrity of analysis and reporting deliverables ensuring deliverables meet pre-specified analysis requirements, internal SOPs, and external regulatory requirements.
- Conduct hands-on exploratory analyses, sample size estimation, modeling and simulation, and create tools to gain useful insights from data as needed.
- Interpret, summarize and present data and statistical considerations to internal project teams and senior management.
- Manage Biostatistics vendors and contract research organizations. Provide oversight on the activities of both in-house staff and external statistical service providers as appropriate.
- Keep up to date on new developments in statistics, drug development in the relevant indication space, and the regulatory environment.
Requirements
- Ph.D. in Statistics or Biostatistics with 5+ years of pharmaceutical experience (or master’s degree in a related discipline with 10+ years of relevant experience).
- Substantive expertise in statistical methodology and its application to solve problems in the pharmaceuticals/biotechnology setting.
- Late-stage clinical experience, Phase 3 planning, conduct, and reporting.
- Strong analytical and problem-solving skills; expert collaboration and communication skills.
- Strong programming skills in R, Markdown/Quarto; working knowledge of git and UNIX/Linux environments.
- Familiarity with industry data standards, including CDISC, SDTM and ADaM data models.
- Ability and interest to work cross functionally with basic science research and clinical colleagues.