Manager/Senior Manager, Statistical Programming, Pulmovant

Role overview A clinical-stage biotechnology organization developing inhaled therapies for serious pulmonary diseases is hiring a Statistical Programming leader to drive late-phase clinical deliverables. The position owns programming for Phase 2b/3 studies and regulatory submissions across a respiratory portfolio with significant unmet need. It collaborates daily with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to keep CDISC-compliant outputs audit-ready.

Responsibilities - Build, validate, and maintain SAS and R programs that produce SDTM and ADaM datasets, along with tables, listings, and figures for clinical studies and submissions - Act as lead programmer on assigned Phase 2b/3 trials, authoring and reviewing programming specifications, QC plans, and define.xml documentation - Align all outputs with statistical analysis plans, protocols, and FDA, EMA, and ICH expectations - Drive programming workstreams for NDA, BLA, and IND submissions, including integrated summaries of safety and efficacy, clinical study reports, and ad hoc regulatory responses - Develop reusable SAS macros, R packages, and internal standards that lift consistency across the programming team - Review eCRF layouts, external data transfer specs, central lab and imaging specs, and protocol deviation plans from a programming angle - Manage timelines, oversee CRO and vendor deliverables, contribute to SOPs, and mentor junior programmers; at the Senior Manager level, may supervise 1–2 direct reports

Requirements - Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master's degree preferred - 5+ years (Manager) or 7+ years (Senior Manager) of statistical programming experience in pharma, biotech, or at a CRO - Advanced proficiency in SAS, including Base, Macro, STAT, and GRAPH - Working knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission requirements such as eCTD and Reviewer's Guides - Track record as lead programmer on at least one late-phase study or regulatory submission - Understanding of GCP, ICH E3/E9, and FDA/EMA submission norms, plus strong attention to detail, communication skills, and ability to juggle multiple priorities

Nice to have - R proficiency for statistical reporting, with Python familiarity as a plus - Experience supporting NDA/BLA submissions and responding to health authority queries - Comfort with Git, automation tooling, or cloud-based programming environments - Exposure to real-world evidence datasets or adaptive trial designs - Background in pulmonary, respiratory, or rare disease therapeutic areas - SAS certification (Base, Advanced, or Clinical Trials Programming)