Director – Biostatistics

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of congenital and acquired forms of hyperinsulinism (HI). Rezolute’s mission is to bring hope and meaningful solutions to patients and families affected by rare diseases through scientific innovation, collaboration, and integrity.

Position Summary

We are seeking an accomplished Director, Biostatistics to provide strategic and operational leadership for the statistical function within a growing, late-stage biopharmaceutical company. The organization currently has two Phase III clinical programs advancing toward regulatory submissions and commercialization, creating an exciting opportunity for a highly experienced statistician to influence development strategy, regulatory interactions, and submission readiness.

The Director, Biostatistics will serve as the lead statistical expert across clinical development programs, partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Statistical Programming, and external vendors. This individual will ensure the design, analysis, interpretation, and reporting of clinical trial data meet the highest scientific and regulatory standards.

Experience in rare disease drug development and NDA/BLA submissions is strongly preferred.

Key Responsibilities

Statistical Leadership

• Provide strategic statistical oversight for Phase III clinical development programs and future lifecycle management activities.
• Lead the development of statistical strategies supporting clinical development plans, regulatory submissions, and post-hoc analyses.
• Serve as the statistical lead for one or more products and represent Biostatistics on cross-functional program teams.
• Advise senior management regarding statistical considerations, development risks, and mitigation strategies.

Clinical Trial Design & Analysis

• Lead the design and statistical methodology for Phase II, Phase III, and long-term extension studies.
• Author and review statistical sections of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), and submission documents.
• Ensure high-quality analysis of efficacy, safety, patient-reported outcomes, and biomarker data.
• Oversee endpoint selection, estimands, multiplicity strategies, interim analyses, and adaptive design considerations where appropriate.

Regulatory & Submission Support

• Lead the statistical components of NDA/BLA/MAA submissions, including integrated efficacy and safety analyses, statistical documentation, responses to agency questions, and preparation for regulatory review and inspection.
• Represent and defend statistical positions in interactions with global regulatory agencies, including FDA, EMA, MHRA, PMDA, and other health authorities.
• Support preparation of briefing packages, meeting materials, and responses to regulatory questions.
• Provide statistical leadership for NDA/BLA/MAA submission activities and inspection readiness.
• Ensure compliance with ICH, FDA, EMA, and other relevant regulatory guidance.

Vendor & Functional Oversight

• Manage and provide scientific and operational oversight of CROs, external biostatistics consultants, and statistical programming vendors.
• Collaborate closely with Statistical Programming to ensure analysis datasets, TLFs, and submission deliverables are generated according to CDISC standards.
• Review and approve key statistical deliverables to ensure quality, timelines, and regulatory compliance.

Cross-Functional Collaboration

• Partner with Clinical Development physicians, 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.

Qualifications

Education

• Ph.D. in Statistics, Biostatistics, Mathematics, or related quantitative discipline preferred.
• Master's degree with significant industry experience will be considered.

Experience

• 10+ years of biostatistical experience within 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.
• Rare disease development experience strongly preferred.
• Prior experience in a small or emerging biotechnology environment is highly desirable.

Technical Skills

• Strong comprehensive knowledge of clinical trial methodology, statistical theory, and regulatory requirements.
• Expertise in ICH E9, 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.

Leadership Competencies

• Strategic thinker capable of balancing scientific rigor with business objectives.
• Strong communication and influencing skills across technical and non-technical stakeholders.
• Comfortable operating in a fast-paced, resource-conscious biotechnology environment.
• Demonstrated ability to manage multiple priorities while meeting aggressive development timelines.
• Collaborative, hands-on leader willing to work at both strategic and operational levels.

Preferred Experience

• Rare disease, orphan drug, or ultra-rare disease development programs, analysis of continuous glucose monitoring in applicable therapeutic areas.
• Experience supporting NDA, BLA, or MAA submissions.
• Exposure to accelerated approval pathways or breakthrough designation programs.
• Experience in a company transitioning from late-stage development to commercialization.
• Prior leadership of biometrics vendors and global development programs.