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.