> Markdown version of [/jobs/ext/3376341-manager-senior-manager-statistical-programming](https://www.wearedevelopers.com/jobs/ext/3376341-manager-senior-manager-statistical-programming). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Manager/Senior Manager, Statistical Programming - **Company:** Pulmovant, Inc. - **Location:** United States (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Cloud Computing, Code Review, Computer Programming, Data Transmissions, Data Governance, Python (Programming Language), Programming Environments, SAS (Software), Git, Information Technology, Data Management, Software Version Control - **Published:** September 30, 2026 - **Apply:** https://startup.jobs/manager-senior-manager-statistical-programming-pulmovant-pulmovant-10220843 ## About the Role * 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 ## 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., * 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