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.