Senior Director of Biostatistics
Role Summary
We are partnered with an oncology‑focused biotechnology company seeking a seasoned biostatistics leader to guide the statistical vision behind its clinical development programs. This role will shape statistical strategy, elevate study design, and ensure scientific and regulatory rigor across a growing oncology portfolio. The Senior Director will collaborate closely with Clinical Development, Regulatory Affairs, Data Management, and Clinical Operations to drive high‑quality program execution.
Key Responsibilities
- Provide statistical leadership and strategic direction across early‑ and late‑phase oncology studies
- Lead clinical trial design and analysis, including sample size modeling, endpoint planning, and randomization strategies
- Oversee statistical deliverables for regulatory submissions, including protocols, SAPs, and CSR contributions
- Partner cross‑functionally to ensure data quality, integrity, and alignment with scientific and operational goals
- Offer expertise on adaptive designs, interim analyses, and innovative methodologies supporting novel oncology platforms (including ADCs and radioligands)
- Manage, mentor, and oversee internal biostatistics team members and external vendors to ensure timely, high‑quality outputs
- Participate in global regulatory interactions (FDA, EMA, etc.), contributing to briefing documents, responses, and statistical justification packages
- Develop and maintain statistical standards and processes consistent with ICH E9, CDISC, and industry best practices
Qualifications
- Ph.D. in Biostatistics, Statistics, or a related quantitative discipline
- 12+ years of biostatistics experience within the pharmaceutical or biotechnology industry, with at least 5 years focused in oncology
- Demonstrated leadership experience managing biostatistics teams and external vendors
- Proven track record contributing to successful IND, NDA, or BLA submissions
- Strong foundation in clinical trial design, regulatory guidance, and modern statistical approaches in oncology
- Experience with ADCs, radioligand therapies, or targeted oncology platforms preferred
- Proficiency in SAS, R, or equivalent statistical programming tools
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