Senior Director, Biostatistics
Olema OncologyBoston, Massachusetts, United States • San Francisco, California, United States • Cambridge, Massachusetts, United States
Posted December 23, 2025
292000 - 308000 USD year
Full Time
About the Company
Olema Oncology is a biotech company dedicated to developing better medicines for breast cancer and beyond.
Job Description
Olema Oncology is a biotech company dedicated to developing better medicines for breast cancer and beyond. The Senior Director, Biostatistics will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities.
Requirements
- Strong understanding of regulatory requirements, industry standards, and guidance documents
- Broad and thorough knowledge of statistical principles and clinical trial methodology
- Comprehensive understanding of RECIST 1.1 guidelines
- Expertise in CDISC standards, including SDTM and ADaM
- Proficiency in SAS and/or R programming
- Demonstrated ability to lead and successfully complete major programs and projects
- Strong analytical, problem-solving, and communication skills
- Experience interacting with regulatory agencies, including the FDA and international health authorities
- 10+ years of experience in the biotech or pharmaceutical industry, with a PhD in Statistics or Biostatistics
- Minimum of 3 years direct leadership experience
- Extensive experience in late-stage oncology drug development, including the design and execution of registrational Phase 3 studies
- Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions
- Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE)
Benefits
- Competitive compensation package
- Equity
- Bonus
- Benefits