Position: Director, Biostatistics
Summary: Pulmovant is seeking a Director of Biostatistics to serve as lead biostatistician for its Phase 3 PHrontier program evaluating mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD). This role will drive statistical strategy for the pivotal trial, partnering closely with Clinical Development, Regulatory, and Data Management to ensure rigorous, submission-ready trial design and analysis. The ideal candidate brings direct experience taking a program through Phase 3 and toward regulatory filing.
KeyDuties and 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 (e.g., NDA/BLA), including 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 (e.g., DSMBs, 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.
Education and Experience - PhD or MS in Biostatistics, Statistics, or related field
- 8+ years of biostatistics experience in clinical drug development, including direct Phase 3 experience
- Prior experience contributing to a regulatory submission (NDA/BLA) strongly preferred
- Pulmonary/respiratory therapeutic area experience a plus
Essential Skills and Abilities - 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
