Director of Biostatistics
Job Summary
Seeking a Director of Biostatistics, the full-time remote position will manage statistical strategy for the Phase 3 PHrontier program evaluating mosliciguat in pulmonary hypertension associated with interstitial lung disease, collaborating with Clinical Development, Regulatory, and Data Management teams to ensure rigorous trial design and analysis.
Key responsibilities
- Serve as lead biostatistician for the Phase 3 PHrontier program, including protocol development and statistical analysis plans
- Collaborate with Clinical Development and Regulatory on trial design decisions and oversee CRO/vendor biostatistics deliverables
- Lead statistical input for regulatory submissions and present statistical results to internal and external stakeholders
Required qualifications
- PhD or MS in Biostatistics, Statistics, or a related field
- 8+ years of biostatistics experience in clinical drug development, with direct Phase 3 experience
- Prior experience contributing to a regulatory submission (NDA/BLA) strongly preferred
- Deep expertise in SAS and/or R for clinical trial analysis
- Strong understanding of ICH/FDA statistical guidance and GCP standards
Complete Job Description
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