Senior Director, Biostatistics

Role Summary

Senior Director of Biostatistics, reporting to the VP of Biostatistics, will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis, and collaborate cross-functionally to support planning, execution, and analysis of the trial. This role is based in San Francisco, CA or Cambridge, MA, with minimal travel.

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.

Qualifications

• Required: Strong understanding of regulatory requirements, industry standards, and guidance documents.
• Required: Broad and thorough knowledge of statistical principles and clinical trial methodology, with the ability to apply best practices in oncology study design and analysis.
• Required: Comprehensive understanding of RECIST 1.1 guidelines.
• Required: Expertise in CDISC standards, including SDTM and ADaM.
• Required: Proficiency in SAS and/or R programming.
• Required: Demonstrated ability to lead and successfully complete major programs and projects.
• Required: Strong analytical, problem-solving, and communication skills.
• Required: Experience interacting with regulatory agencies, including the FDA and international health authorities.
• Required: PhD in Statistics or Biostatistics.
• Required: Minimum of 3 years direct leadership experience.
• Required: Extensive experience in late-stage oncology drug development, including the design and execution of registrational Phase 3 studies.
• Required: Proven experience in regulatory interactions, with a strong track record of NDA or sNDA submissions.
• Required: Experience building a biostatistics strategy and execution of a global NDA submission (Phase 3, ISS, ISE).
• Required: Demonstrated ability to manage CROs in the conduct and analysis of clinical trials.
• Required: Proven ability to represent Biostatistics effectively in multidisciplinary meetings.
• Required: Strong history of effective collaboration across cross-functional teams.
• Preferred: Leadership skills including proactive strategic thinking, prioritization, adaptability, conflict resolution, and partnership-building.
• Preferred: Deep statistical expertise and experience overseeing the statistical components of clinical trials.
• Preferred: Ability to develop innovative and creative statistical and technical solutions to complex problems.
• Preferred: Excellent verbal and written communication skills.
• Preferred: Self-motivated and enthusiastic, with the ability to quickly learn, identify core project challenges, and adapt to evolving requirements in a fast-paced environment.

Education

• PhD in Statistics or Biostatistics.

Skills

• CDISC SDTM and ADaM expertise
• SAS and/or R programming proficiency
• Regulatory interaction experience (FDA and international health authorities)
• Strong analytical, problem-solving, and communication skills
• Leadership and mentorship capabilities