Hybrid Senior Director, Biostatistics presso Olema

About the Role >>> Senior Director, Biostatistics

As the Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will play an instrumental role in leading the statistical aspects of a pivotal Phase 3 clinical trial. You will leverage your technical expertise to apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis. Additionally, you will collaborate cross-functionally to support the planning, execution, and analysis of the trial.

This role is based out of our San Francisco, CA office and will require minimal travel.

Your work will primarily encompass:

• Serve as the biostatistics lead in designing phase 3 clinical trials, ensuring scientific rigor and compliance with regulatory requirements.
• Apply innovative statistical methodologies to optimize study design, analysis strategies, data exploration, and presentation.
• Author briefing books for regulatory interactions and address questions/comments from regulatory agencies, IRBs, and ECs.
• Lead statistical activities for regulatory submissions.
• Develop and author the Statistical Analysis Plan including TLF shells, DMC charter, and study protocol.
• Provide statistical input for clinical study reports (CSR), IB, DSUR, and other study-level documents.
• Oversee the development of SDTMs, ADAMs and TLFs to ensure accuracy and regulatory compliance.
• Conduct rigorous quality control checks on key study endpoint analyses and submission deliverables.
• Manage the CRO on DMC deliveries and ensure high-quality outcomes.
• Responsible for one or more studies with concurrent tasks and timelines.

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• Strong knowledge of regulatory requirements, industry standards, and guidance documents.
• Broad and thorough understanding of statistical principles and clinical trial methodology, with the ability to apply and implement best practices in study design and analysis.
• Expertise in CDISC standards, including SDTM and ADaM specifications.
• Proficiency in SAS and/or R programming.
• Ability to lead and successfully complete major programs and projects.
• Strong analytical, problem solving, and communication skills.
• Experience working with regulatory agencies, including the FDA and international health authorities.

Experience:

• 8+ years (with PhD degree) or 10+ years (with Master’s degree) in the biotech or pharmaceutical industry.
• 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 record of regulatory submissions and approvals in oncology (preferred).
• Demonstrated ability to manage CROs for the conduct and analysis of clinical trials.
• Proven ability to represent Biostatistics effectively in multidisciplinary meetings.
• Proven ability to collaborate effectively across cross-functional teams.

Attributes:

• Strong leadership skills in proactive strategy development, prioritization, adaptation to change, conflict resolution, and building effective partnerships.
• Expertise in statistics and experience managing the statistical aspects of clinical trials.
• Ability to develop innovative and creative statistical and technical solutions to complex problems.
• Strong verbal and written communication skills.
• Commitment to excellence, consistently striving to deliver high-quality results.
• Self-motivated and enthusiastic with a strong ability to quickly learn, identify core project challenges, and adapt to changing requirements in a fast-paced environment.
• Possess impeccable professional ethics, integrity and judgment

The base pay range for this position is expected to be $290,000 - $310,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1