Pulmovant

Director

• Lead, build, and oversee the Biostatistics and Statistical Programming functions, establishing standards, processes, and infrastructure to support a growing pipeline.
• Serve as the senior biostatistical leader across Pulmovant’s programs, including the Phase 2 PHocus and PHactor studies of mosliciguat in PH-ILD, and future late-stage and registrational studies.
• Provide strategic statistical input into protocol design, sample size justification, statistical analysis plans (SAPs), and integrated analyses (ISS/ISE) supporting regulatory submissions.
• Review data quality, completeness, and key derivations
• Review and provide feedback and QC on TLF shells and outputs
• Ensure deliverables meet SAP specifications and quality standards
• Confirm readiness of TLR package for internal/external use
• Partner with Clinical Development, Regulatory Affairs, and Clinical Operations to define endpoints, estimands, and analysis strategies aligned with FDA, EMA, and other global health authority expectations.
• Oversee CRO biostatistics and statistical programming deliverables, ensuring quality, timeliness, and adherence to CDISC (SDTM/ADaM), FDA, and ICH E9/E9(R1) standards.
• Lead preparation of biometrics components of regulatory submissions (IND, EOP2, NDA/MAA) and represent Pulmovant in interactions with FDA and other agencies.
• Drive innovative analytical approaches, including adaptive designs, Bayesian methods, and use of historical or external controls where appropriate for a rare-disease setting.
• Build and lead a high-performing team of biostatisticians and statistical programmers; mentor staff and shape the talent strategy as Pulmovant scales.
• Support data monitoring committees (DMCs), trial steering committees, and key opinion leader engagements.
• Contribute to publications, scientific communications, and conference presentations of clinical trial results.

Senior Director – Biometrics