Senior Director / Head of Biometrics, Pulmovant

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Pulmovant recently completed enrollment in the Phase 2 PHocus study evaluating mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), with topline data expected in the second half of 2026. Mosliciguat is also being evaluated in the Phase 2 PHactor study in combination with inhaled treprostinil in patients with PH-ILD.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.

For more information, please visit https://www.pulmovant.com.

About Roivant:

Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Position: Senior Director / Head of Biometrics

Summary:

Pulmovant is seeking an accomplished biostatistician to lead the Biometrics function. This individual will own and build the Biostatistics and Statistical Programming functions, providing strategic and operational leadership across all of Pulmovant’s clinical development programs.

This is a high-impact opportunity at a pivotal moment for the company. With enrollment recently completed in the Phase 2 PHocus study of mosliciguat in PH-ILD and topline results expected in the second half of 2026, the Head of Biometrics will play a critical role in shaping the analysis, regulatory strategy, and registrational path for a potential first-in-class inhaled sGC activator. The successful candidate will partner closely with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and external CROs to deliver high-quality, regulatory-grade biometrics deliverables and to scale a fit-for-purpose function as the pipeline advances.

Key Duties and Responsibilities 

• 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.

Education and Experience 

• PhD in Biostatistics, Statistics, or a closely related quantitative field (MS with extensive industry experience may be considered).
• 12+ years (Senior Director) or 15+ years (Vice President) of biostatistics experience in the biopharmaceutical industry, including significant time leading biostatistics across late-stage development and regulatory submissions.
• Demonstrated experience leading both Biostatistics and Statistical Programming functions, including oversight of CRO partners.
• Track record of leading biostatistical strategy through successful regulatory interactions and submissions (IND, NDA/BLA, MAA); FDA submission experience required.
• Prior experience in pulmonary, cardiovascular, rare disease, or interstitial lung disease therapeutic areas is strongly preferred; experience with PH or PH-ILD a plus.
• Experience working in a small or mid-cap biotech and operating effectively in a lean, fast-paced environment.

Essential Skills and Abilities 

• Deep expertise in statistical methodology for clinical trials, including adaptive designs, longitudinal/mixed models, survival analysis, missing data, and estimands per ICH E9(R1).
• Working knowledge of statistical programming in SAS and R; expert understanding of CDISC (SDTM, ADaM) standards and submission deliverables.
• Strong regulatory acumen and ability to translate complex statistical concepts into clear narratives for regulators, executives, and clinical partners.
• Proven leadership and people-management skills; ability to attract, develop, and retain top biometrics talent.
• Excellent written and verbal communication skills, with comfort presenting to executives, regulators, DMCs, and external KOLs.
• Strategic mindset paired with a hands-on willingness to operate at all levels in a small-company setting.
• Strong cross-functional collaboration skills with Clinical Development, Clinical Operations, Data Management, Regulatory, and Medical Affairs.
• Proficient in vendor and CRO management, with proven ability to drive quality and timelines.
• High personal integrity, scientific rigor, and unwavering commitment to patients.

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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