Executive Director, Head of Biostatistics

Overview

Executive Director/Senior Director, Head of Biostatistics – Direct Hire:
Full time, direct employee of our client.

Location:

South San Francisco, CA (hybrid with 2-3 days on-site per week). Relocation option potential for the right experience.

Salary: $260-350k. Salary is based on level of experience; total package includes bonus potential and equity options.

The Head of Biostatistics will report directly to the EVP, Chief Development Officer, and will be responsible for leading the biostatistics efforts for all clinical development programs. This role will provide strong scientific and technical operational oversight across all clinical trials to ensure rigorous statistical methodology, data integrity, and regulatory compliance. The ideal candidate should be a collaborative leader with a proven track record of guiding cross-functional teams through early and late-stage clinical trial designs, data analyses, and be familiar with global regulatory requirements for statistical data submissions.

The level of the role will depend on experience. The candidate will oversee and manage external vendors and consultants responsible for day-to-day statistical programming and analysis. The candidate must have a proven track record of contributing to regulatory submissions such as INDs, NDAs or MAAs.

• Provide statistical input across clinical development programs, including clinical trial study design, clinical protocol development, authoring and reviewing statistical analysis plans, and analysis planning.
• Provide expertise in designing complex clinical trials including trials with adaptive design and platform trials.
• Author and/or review protocols, electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses, clinical study reports including statistical methods and interpretation of study results.
• Manage external CROs/consultants to ensure on-time, high-quality statistical support and deliverables.
• Lead the development and review of key documents, including statistical analysis plans, clinical study reports, and regulatory filings (e.g., NDA, MAA).
• Represent biostatistics in interactions with regulatory agencies, including preparing responses and meeting participation.
• Ensure compliance with industry and regulatory standards, including ICH, GCP, FDA, EMA, and CDISC.
• Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatistics templates and standards.

• PhD degree in statistics, biostatistics, or related quantitative field.
• A minimum of 10+ years’ experience in biostatistics supporting clinical trials in pharmaceutical, biotech or CRO.
• Proven track record of managing external clinical biostatistics team.
• Extensive experience designing complex late-stage clinical trials (e.g., basket, platform, umbrella or factorial designs).
• Expert knowledge of statistical methods for clinical trials, regulatory guidelines, and CDISC standards (SDTM, ADaM).
• Excellent proficiency in statistical software (e.g., SAS, R).
• Experience with worldwide global regulatory interactions and submissions with hands-on experience contributing to INDs, NDAs, MAAs, or other regulatory submissions.
• Experience in cross-functional drug development strategies including clinical development planning, go/no-go decision-making, strategic and technical governance review, working with data safety monitoring boards, and late-stage study execution.
• Ability to develop fit-for-purpose innovative statistical solutions to meet development program needs. Deep early and late-stage development experience.
• Excellent written and oral communication, leadership, and project management skills.
• Experience managing budgets.
• Ability to be onsite (hybrid with 3 days onsite a week) and travel as needed around 5%.
• Must be authorized to work in the United States.

• Familiarity with trial designs for antivirals and liver diseases such as NASH.

• A…