Position: Manager / Senior Manager, Statistical Programming
Summary: 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.
KeyDuties 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
Education and Experience - 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
