[Hiring] Director of Biostatistics @Pulmovant

Role Description

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.

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.

Qualifications

• 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.

Requirements

• 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.

Company Description

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.