Position: Senior Director, Biostatistics

Summary:
A leading biopharmaceutical company is seeking a Senior Director, Biostatistics to lead statistical strategy and operations across clinical development programs. This role will work closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Clinical Pharmacology, Data Management, and Translational Medicine, to ensure the rigorous design, analysis, and interpretation of clinical data. The position involves overseeing biostatistics personnel, managing external vendors, contributing to regulatory submissions, and supporting drug approvals on a global scale.

Key Responsibilities:

• Lead and mentor the biometrics team, providing strategic input and statistical expertise across clinical programs.
• Guide the development of clinical plans and protocols in collaboration with clinical operations, clinical sciences, regulatory, and commercial teams.
• Establish statistical standards and methodologies to ensure the quality and integrity of clinical, translational, and pharmacology datasets.
• Oversee and review key study documents, including protocols, statistical analysis plans (SAPs), case report forms (CRFs), and clinical study reports (CSRs).
• Manage internal biostatistics personnel and external vendors to produce high-quality statistical outputs and analyses.
• Serve as a key statistical representative in regulatory discussions and submissions, contributing to regulatory strategies and defending statistical methodologies.
• Stay up to date with evolving statistical methodologies and regulatory requirements to ensure best practices in clinical trial design and analysis.

Qualifications & Skills:

• Ph.D. or M.S. in Statistics or a related field.
• 15+ years of statistical experience in drug development, with at least 10 years focused on oncology.
• Extensive hands-on experience in clinical trial design, statistical analysis, and regulatory submissions.
• Direct involvement in multiple NDA/BLA submissions, with a track record of regulatory approvals in oncology.
• Strong expertise in time-to-event analysis and oncology clinical trial methodologies.
• Demonstrated leadership in cross-functional team environments, with excellent communication and organizational skills.

This position offers an exciting opportunity to play a critical role in advancing oncology drug development within a highly collaborative and innovative environment.