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Director Biostatistics

Virtual Vocations Inc

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 Virtual Vocations Inc

Vacancy posted 1 day ago
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