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r leadership sas biostatistics regulatory submissions📋 Description
- Lead statistical strategy for late-stage development.
- Partner with Clinical Development, Regulatory, and Translational Medicine to ensure rigorous trial execution.
- Manage and mentor the Biostatistics team to deliver high-quality outputs.
- Drive regulatory interactions and submissions readiness across programs.
- Align internal teams and external partners on statistics strategy and priorities.
- Report to Head of Biometrics and contribute to strategic leadership.
🎯 Requirements
- PhD in Statistics/Biostatistics with 12+ years in biotech/pharma, or MS with 15+ years.
- Proven leadership of a biostatistics team in late-stage trials.
- Expertise in Phase 3 trials, regulatory submissions, and safety data.
- Proficiency in R and SAS; Bayesian methods and adaptive designs.
- Experience with trial simulations and quantitative decision-making.
- Experience with internal and external (CRO) statistical work and oversight.
🎁 Benefits
- Base salary range: $219,000 - $329,000 USD.
- Annual bonus.
- Equity compensation.
- Comprehensive benefits package.
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