[Hiring] Manager/Senior Manager, Statistical Programming @Pulmovant

Role Description

Pulmovant is seeking a Manager or Senior Manager of Statistical Programming to support the development and delivery of high-quality, submission-ready programming deliverables across our pulmonary/respiratory clinical portfolio. This individual will serve as a lead programmer on clinical studies and regulatory submissions, working closely with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to ensure that all CDISC-compliant datasets, TLFs, and electronic submission packages meet the highest standards of quality and regulatory compliance.

Key Duties and Responsibilities

• Develop, validate, and maintain SAS and R programs to produce CDISC-compliant SDTM and ADaM datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions.
• Serve as lead programmer for assigned Phase 2b/3 studies; author and review programming specifications, QC plans, and define.xml files.
• Ensure all deliverables are audit-ready and aligned with SAPs, protocols, and applicable FDA/EMA/ICH regulatory guidelines.
• Contribute to the development and maintenance of reusable SAS macro libraries, R packages, and programming standards to improve efficiency and consistency across programs.
• Lead or support statistical programming activities for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), CSRs, and ad hoc regulatory requests.
• Ensure compliance with CDISC SDTM/ADaM implementation guides, FDA Data Standards Catalog, and eCTD submission requirements; author and review Reviewer's Guides and define.xml.
• Review and provide input on eCRF designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans from a programming perspective.
• Represent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs to align on timelines and deliverables.
• Plan and manage programming timelines and resources across assigned studies; oversee and quality-check deliverables from CROs and external programming vendors.
• Contribute to or lead development of departmental SOPs, work instructions, and process improvement initiatives related to statistical programming.
• Mentor junior statistical programmers; provide technical guidance, code review, and support for professional development.
• At the Senior Manager level, may manage 1–2 direct reports and provide input on hiring, performance, and team-building as the function grows.

Qualifications

• Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master's degree preferred.
• 5–7+ years of statistical programming experience in pharma, biotech, or a CRO (Manager: 5+ years; Senior Manager: 7+ years).
• Advanced proficiency in SAS (Base, Macro, STAT, GRAPH) required.
• Thorough knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission requirements (FDA eCTD, define.xml, Reviewer's Guides).
• Proven experience as lead programmer on at least one late-phase (Phase 2b/3) clinical study and/or regulatory submission.
• Strong understanding of GCP, ICH E3/E9 guidelines, and FDA/EMA data submission expectations.

Essential Skills and Abilities

• Excellent attention to detail, communication skills, and ability to manage multiple projects and priorities simultaneously.
• Proficiency in R for statistical programming and reporting; familiarity with Python a plus.
• Experience supporting NDA/BLA submissions and responding to health authority queries.
• Familiarity with automation tools, version control (Git), and/or cloud-based programming environments.
• Exposure to real-world evidence (RWE) datasets or adaptive trial designs.
• Experience in pulmonary, respiratory, or rare disease therapeutic areas.
• SAS certification (Base, Advanced, or Clinical Trials Programming) a plus.

Company Description

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

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