Director, Biostatistics

Key Responsibilities:
- Contribute to strategic thinking and Clinical Development Plan (CDP) development.
- Lead large and/or complex late-phase clinical development program(s).
- Collaborate to design innovative clinical trials.
- Author statistical sections of clinical trial protocols and statistical analysis plans.
- Review and approve stratification/randomization schema.
- Collaborate on eCRF design with Data Management, Clinical Development, and Clinical Operations.
- Provide statistical guidance on ongoing trial conduct.
- Collaborate with Statistical Programmers on trial data summary/analysis; write ADaM and ad hoc analysis specifications.
- Interpret and communicate statistical results for regulatory submissions and manuscripts.
- Contribute to clinical study reports and regulatory documents (e.g., DSURs, Briefing Documents).
- Lead biostatistics support for worldwide regulatory submissions.
- Represent the company in meetings with regulators, KOLs, partners, and other stakeholders.
- Contribute to scientific articles summarizing trial data.
- Consult with Research, Preclinical, Clinical Pharmacology, Medical Affairs, and Commercial teams on statistical questions.
- Manage timelines across the clinical development program.

Qualifications:
- Ph.D. in Statistics/Biostatistics (or equivalent) with 8–10+ years pharmaceutical statistics experience (preferred).
- Excellent written/oral communication and presentation skills.
- Experience designing/supporting Phase 2/3 studies.
- Experience conducting clinical trial simulations.
- Interest in and basic understanding of biology/biological processes, including RNAi.

Experience/Skills:
- Bayesian and adaptive clinical trial design.
- Experience leading/supporting NDA and MAA submissions.
- Proficiency in SAS and R.
- Experience representing sponsors in meetings with US FDA and international regulators.