Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Senior Director of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will collaborate cross-functionally to support the planning, execution, and analysis of the trial.
Requirements
- Strong understanding of regulatory requirements, industry standards, and guidance documents.
- Broad and thorough knowledge of statistical principles and clinical trial methodology, with the ability to apply best practices in oncology study design and analysis.
- 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)
- Demonstrated ability to manage CROs in the conduct and analysis of clinical trials.
- Proven ability to represent Biostatistics effectively in multidisciplinary meetings.
- Strong history of effective collaboration across cross-functional teams.
- Attributes: Strong leadership skills, including proactive strategic thinking, prioritization, adaptability, conflict resolution, and partnership-building.
Benefits
- Competitive compensation and benefits package
- Equity, bonus, and benefits
- Open, flexible, and friendly work environment
- Platform to develop long-term careers
