Head of Biostatistics

Job Title: Head of Biostatistics

Location: Boston

Position Overview: The Head of Biostatistics will play a critical role in shaping and executing biostaistics strategies across both clinical and diagnostic development. The ideal candidate will bring deep technical expertise (Clinical and Diagnostic), strong leadership capabilities, and a proven track record of success within Oncology.

Key Responsibilities:

• Collaborate with cross-functional teams to support clinical development and regulatory submissions
• Provide biostatistical leadership across all phases (I-IV) of clinical trials
• Ensure the quality and scientific integrity of diagnostic development initiatives, encompassing but not limited to biomarker and correlative studies
• Foster strong collaborative relationships with internal and external stakeholders (CRO Oversight)
• Provide strategic input to clinical development plans and product lifecycle management.
• Oversee the preparation and review of statistical sections for regulatory submissions

Experience:

• Education: PhD in Biostatistics, Statistics, Mathematics
• 12+ Years of Industry Experience (Clinical and Diagnostic Development Experience)
• Effectively communicates complex statistical analyses and issues to non-statisticians.
• Proficiency in statistical software (e.g., SAS, R) and data management systems.
• 6+ years of direct, hands-on experience in Oncology