Oncology Biostatistics Director

Job Summary

A company is looking for a Senior Director, Biostatistics - Oncology.

Key Responsibilities

• Lead the development of statistical sections for clinical study protocols and analysis plans, and conduct data analysis and reporting
• Oversee CRO statistical activities and manage contractor statisticians to ensure timely delivery of high-quality outputs
• Collaborate with internal and external teams on projects, ensuring accountability for all statistical deliverables

Required Qualifications

• Minimum of MS in Statistics, Biostatistics, or related fields (Ph.D. preferred)
• 12+ years of experience for MS (8+ years for Ph.D.), including 10+ years in drug development in a CRO or pharma/biotech company
• Strong oncology experience, familiar with drug development, efficacy endpoints, and statistical issues in oncology
• Regulatory NDA/BLA submission experience is strongly preferred
• Hands-on experience with SAS programming in clinical studies and managing CROs and contractors