Senior Director, Biostatistics

Role Summary

Senior Director of Biostatistics, reporting to the VP of Biostatistics, you 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 either 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

• Knowledge: Strong understanding of regulatory requirements, industry standards, and guidance documents; comprehensive understanding of RECIST 1.1; CDISC standards (SDTM/ADaM); proficiency in SAS and/or R; experience interacting with regulatory agencies (FDA and international health authorities).
• Experience: 10+ years in biotech/pharma with a PhD in Statistics or Biostatistics; minimum 3 years direct leadership; extensive late-stage oncology drug development experience including registrational Phase 3 studies; proven NDA/sNDA submission experience; experience managing CROs and representing Biostatistics in multidisciplinary meetings; strong cross-functional collaboration.
• Attributes: Strong leadership, strategic thinking, adaptability, conflict resolution, partnership-building; deep statistical expertise; ability to develop innovative statistical solutions; excellent verbal and written communication; ethical judgment and high-quality work delivery; fast learner and capable of addressing evolving project requirements.

Skills

• Analytical, problem-solving, and communication skills.
• Statistical leadership across multiple projects and ability to influence cross-functional teams.
• Proficiency in SAS and/or R programming.

Education

• PhD in Statistics or Biostatistics.

Additional Requirements

• Location: San Francisco, CA or Cambridge, MA.
• Travel: minimal travel required (~10%).