Director, Biostatistics
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Job Description
Director of Biostatistics leading statistical strategy for Pulmovant’s Phase 3 PH-ILD trial. Driving regulatory-ready analyses for its inhaled mosliciguat treatment.
Responsibilities:
- Serve as lead biostatistician for Pulmovant's Phase 3 PHrontier program, including protocol development, statistical analysis plans (SAPs), and sample size/power calculations
- Partner with Clinical Development and Regulatory on trial design decisions, including endpoint selection and interim analysis strategy
- Oversee CRO/vendor biostatistics deliverables, ensuring quality and timeline adherence
- Lead statistical input for regulatory submissions, including NDA/BLA submissions and responses to health authority queries
- Collaborate with Data Management on CRF design, database structure, and data quality standards
- Present statistical results and methodology to internal leadership and external stakeholders, including DSMBs and advisory boards
- Mentor junior biostatistics staff or contractors as the function scales
- Contribute to departmental initiatives, standards, process improvements, talent development, resource planning, and inspection readiness
Requirements:
- PhD or MS in Biostatistics, Statistics, or related field
- 8+ years of biostatistics experience in clinical drug development, including direct Phase 3 experience
- Deep expertise in SAS and/or R for clinical trial analysis
- Strong understanding of ICH/FDA statistical guidance and GCP, ICH standards, and CDISC principles
- Experience managing CRO biostatistics relationships
- Excellent cross-functional communication skills, able to translate statistical findings for non-statistician stakeholders
- Comfortable operating in a lean, scaling clinical-stage environment
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