Director Biostatistics

A global, commercial‑stage biopharma company focused on rare genetic and cardiometabolic diseases is seeking a Director of Biostatistics o provide strategic and technical leadership across large, complex late‑phase clinical development programs. This role is ideal for a senior biostatistician who excels in innovative trial design, regulatory strategy, and cross‑functional collaboration. Job Overview: Drive statistical strategy and contribute to Clinical Development Plan (CDP) development. Lead biostatistics support for large and/or complex Phase 2/3 programs. Partner with Clinical Development, Regulatory, and Clinical Operations to design innovative clinical trials. Author statistical sections of protocols and statistical analysis plans (SAPs). Review and approve stratification/randomization schemas. Collaborate with Data Management and Clinical Operations on eCRF design. Provide statistical guidance throughout trial conduct and execution. Work closely with Statistical Programmers on data summaries, ADaM specifications, and ad hoc analyses. Interpret and communicate statistical results for regulatory submissions, publications, and internal decision‑making. Contribute to clinical study reports, DSURs, briefing documents, and other regulatory deliverables. Lead biostatistics support for global regulatory submissions (NDA/MAA). Represent the sponsor in meetings with regulators, KOLs, partners, and external stakeholders. Support cross‑functional colleagues (Research, Preclinical, Clinical Pharmacology, Medical Affairs, Commercial) on statistical questions. Manage timelines and deliverables across assigned clinical programs. Key Requirements: PhD in Statistics, Biostatistics, or related field (preferred). 8+ years of biostatistics experience in the pharmaceutical or biotech industry. Strong background in late‑phase (Phase 2/3) clinical trial design and support. Experience conducting clinical trial simulations to evaluate design options and operating characteristics. Experience with Bayesian and adaptive trial design. Strong background in simulation‑based methodological evaluation and independent research, supported by a proven publication record and expertise in reviewing statistical literature and conducting simulations and analyses. Experience supporting regulatory submissions including prior experience interacting with FDA and international regulatory authorities. Proficiency in SAS and R. Excellent communication, presentation, and cross‑functional collaboration skills. #J-18808-Ljbffr Green Key Resources