Senior Director of Biostatistics
EPM Scientific, Palo Alto, CA, United States
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 contributionsPartner 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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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 contributionsPartner 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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