Senior Director, Biostatistics

Olema Oncology•San Francisco, CA

4d•$292,000 - $308,000•Onsite

About The Position

As the Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will play an instrumental role in leading the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. 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 in either our San Francisco, CA or Cambridge, MA office and will require minimal travel (about 10%).

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.
Experience: 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.
Strong leadership skills, including proactive strategic thinking, prioritization, adaptability, conflict resolution, and partnership-building.
Deep statistical expertise and experience overseeing the statistical components of clinical trials.
Ability to develop innovative and creative statistical and technical solutions to complex problems.
Excellent verbal and written communication skills.
Commitment to excellence and consistently delivering high-quality work.
Self-motivated and enthusiastic, with the ability to quickly learn, identify core project challenges, and adapt to evolving requirements in a fast-paced environment.
Possesses impeccable professional ethics, integrity, and judgment.

Responsibilities

Lead the biostatistics strategy and execution for a pivotal Phase 3 trial and ISS/ISE, ensuring scientific rigor and global regulatory alignment.
Apply innovative statistical methods to optimize study design, analysis strategies, and data interpretation.
Develop and author key statistical documents.
Lead statistical activities for regulatory submissions and prepare briefing materials for health authority interactions.
Provide statistical input for CSRs, IBs, DSURs, and other study-level and submission documents.
Oversee development of SDTM, ADaM, and TLF deliverables to ensure accuracy and compliance with regulatory and CDISC standards.
Manage CRO statistical activities, including DMC deliverables, to ensure high-quality execution.
Manage and mentor junior statisticians as applicable.
Provide statistical leadership across multiple projects with overlapping timelines, as needed.