Principal Biostatistician

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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

1. 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.
2. Accountable for accuracy and statistical integrity of analysis and reporting deliverables ensuring deliverables meet pre-specified analysis requirements, internal SOPs, and external regulatory requirements.
3. Conduct hands-on exploratory analyses, sample size estimation, modeling and simulation, and create tools to gain useful insights from data as needed.
4. Interpret, summarize and present data and statistical considerations to internal project teams and senior management.
5. Manage Biostatistics vendors and contract research organizations. Provide oversight on the activities of both in-house staff and external statistical service providers as appropriate.
6. 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.

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