Director – Biostatistics

Rezolute • Redwood City, CA

4d

About The Position

Rezolute is a late-stage rare disease biopharmaceutical company developing therapies for severe metabolic and endocrine disorders. The Director, Biostatistics will provide strategic and operational leadership for the statistical function as two Phase III clinical programs advance toward regulatory submissions and commercialization. The role serves as lead statistical expert across clinical development programs, partnering with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Statistical Programming, and external vendors to ensure trial design, analysis, interpretation, and reporting meet scientific and regulatory standards.

The Director will lead statistical strategy and execution for late-stage development programs, contribute to regulatory interactions and NDA/BLA/MAA submission readiness, and advise senior management on statistical considerations and development risks. The position also provides oversight of external vendors and statistical deliverables, collaborates across functions, and mentors junior statisticians. Rare disease experience and NDA/BLA submission experience are strongly preferred.

Requirements

• 10+ years of biostatistical experience in the pharmaceutical, biotechnology, or CRO industry.
• Experience serving as lead statistician for late-stage clinical development programs.
• Demonstrated involvement in Phase III clinical trials and regulatory submissions.
• Experience supporting FDA and/or EMA interactions.
• Strong comprehensive knowledge of clinical trial methodology, statistical theory, and regulatory requirements.
• Expertise in ICH E9, the estimands framework, adaptive trial designs, longitudinal data analysis, multiplicity methodologies, and missing data strategies.
• Working knowledge of CDISC SDTM and ADaM standards.
• Familiarity with SAS and R programming environments.
• Experience reviewing outputs, analyses, and submission deliverables generated by statistical programming teams.
• Strategic thinking and ability to balance scientific rigor with business objectives.
• Strong communication and influencing skills across technical and non-technical stakeholders.
• Ability to operate in a fast-paced, resource-conscious biotechnology environment and manage multiple priorities against aggressive timelines.
• Collaborative, hands-on leadership across strategic and operational work.

Nice To Haves

• Ph.D. in Statistics, Biostatistics, Mathematics, or a related quantitative discipline; a master's degree with significant industry experience will be considered.
• Rare disease development experience.
• Experience in a small or emerging biotechnology environment.
• Experience with rare disease, orphan drug, or ultra-rare disease programs.
• Experience analyzing continuous glucose monitoring data in applicable therapeutic areas.
• Experience supporting NDA, BLA, or MAA submissions.
• Exposure to accelerated approval pathways or breakthrough designation programs.
• Experience at a company transitioning from late-stage development to commercialization.
• Prior leadership of biometrics vendors and global development programs.

Responsibilities

• Provide strategic statistical oversight for Phase III clinical development programs and lifecycle management activities.
• Develop statistical strategies for clinical development plans, regulatory submissions, and post-hoc analyses.
• Serve as statistical lead for one or more products and represent Biostatistics on cross-functional program teams.
• Advise senior management on statistical considerations, development risks, and mitigation strategies.
• Lead design and statistical methodology for Phase II, Phase III, and long-term extension studies.
• Author and review statistical sections of protocols, statistical analysis plans, clinical study reports, and submission documents.
• Ensure high-quality analyses of efficacy, safety, patient-reported outcomes, and biomarker data.
• Oversee endpoint selection, estimands, multiplicity strategies, interim analyses, and adaptive design considerations where appropriate.
• Lead statistical components of NDA/BLA/MAA submissions, including integrated analyses, documentation, agency responses, and regulatory review and inspection preparation.
• Represent and defend statistical positions in interactions with global regulatory agencies, including FDA, EMA, MHRA, and PMDA.
• Support preparation of briefing packages, meeting materials, and responses to regulatory questions.
• Ensure compliance with ICH, FDA, EMA, and other relevant regulatory guidance.
• Manage and provide scientific and operational oversight of CROs, external biostatistics consultants, and statistical programming vendors.
• Collaborate with Statistical Programming to ensure analysis datasets, tables, listings, and figures, and submission deliverables follow CDISC standards.
• Review and approve key statistical deliverables for quality, timelines, and regulatory compliance.
• Partner with Clinical Development, Clinical Operations, Data Management, Safety, and Regulatory Affairs to support program objectives.
• Present statistical findings to senior leadership, advisory boards, investigators, and external stakeholders.
• Mentor and develop junior statisticians and contribute to the growth of the Biometrics organization.

Benefits

• Annual performance bonus, subject to the applicable plan and company and individual performance.
• Health insurance (medical, dental, and vision).
• Disability, life, and long-term care insurance.
• Holiday pay.
• Tracking Free Vacation Program.
• 401(k) plan match.
• Educational assistance benefit.
• Fitness center reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Director