Director, Biostatistics

Pulmovant, a Roivant-backed clinical-stage biotechnology company, is seeking a Director of Biostatistics to lead the Phase 3 PHrontier program evaluating mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD). This role will drive the statistical strategy for the pivotal trial, collaborating closely with Clinical Development, Regulatory, and Data Management to ensure rigorous, submission-ready trial design and analysis. The ideal candidate has direct experience taking a program through Phase 3 and toward regulatory filing.

Key Duties 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:

• A PhD or MS in Biostatistics, Statistics, or a 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 is 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.