Job Description

Senior Director, Biostatistics

Full Time

Onsite 4 days per week. Relocation assistance is available.

Summary: The Senior Director, Biostatistics will lead Biostatistics and Biometrics, overseeing statistical support for therapeutic development. Collaborating with Clinical Development, Regulatory Affairs, Drug Safety, Clinical Pharmacology, Data Management, Translational Development, and Program Management, this role contributes to Clinical Development Plans, clinical protocols, SAPs, regulatory submissions, and publications. The position involves managing the biostatistics team to ensure high-quality, timely deliverables and representing the company on statistical issues globally. Significant stakeholder management and interaction with external vendors, key opinion leaders, and regulatory agencies are required. This role is based in South San Francisco and requires onsite presence four days per week.

Responsibilities:

• Lead Biometrics members in cross-functional teams.
• Provide strategic input to clinical teams, oversee development plans and protocols.
• Set statistical standards and methods for quality delivery of datasets.
• Oversee, author, review, and approve study documents.
• Manage biostatistical teams, ensuring high-quality deliverables.
• Mentor development teams, translating scientific questions into statistical terms.
• Resolve stakeholder concerns and represent biostatistics internally and externally.
• Stay current with statistical methodology and regulatory standards.

Requirements:

• Ph.D. or M.S. in Statistics or related field.
• 15+ years of statistical experience in drug development, including 10 years in oncology.
• Experience in writing protocols and SAPs, performing analyses, and regulatory submissions.
• Direct involvement in multiple NDA/BLA submissions with approval track records.
• Expert knowledge of clinical trial design and statistical methodologies.
• Strong leadership and cross-functional team collaboration skills.

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