Manager, Statistical Programming

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity. Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders More information can be found at rezolutebio.com   Position Summary The Manager of Statistical Programming is responsible for delivering study-level programming deliverables and milestones. The role combines hands-on programming in SAS and R with oversight of a small team or of CRO programmers assigned to a study. The position requires working knowledge of statistical programming languages and software, clinical trial data, and the drug development process. The incumbent develops and oversees programs that generate CDISC-compliant SDTM and ADaM datasets, TLFs, and reports supporting the review of clinical data. The incumbent also writes validation programs and general-purpose code, prepares documentation to support electronic submissions, and contributes to programming standards and templates.