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