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
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