Reporting to the Head of Biometrics, this individual will serve as Vors global expert in biostatistical science, with accountability for all aspects of clinical trial design, statistical methodology, regulatory submission deliverables, and cross-functional scientific partnership. Regulatory Affairs & Submission Leadership • Author and review statistical sections of regulatory documents including INDs, investigator brochures, briefing books, CSRs, and eCTD/CTD module submissions to FDA, EMA, and other health authorities.