Manager/Senior Manager, Statistical Programming

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 22%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 Description

• 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 • 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 • Represent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs • Plan and manage programming timelines and resources; oversee and quality-check deliverables from CROs and external programming vendors • Contribute to or lead departmental SOPs, work instructions, and process improvement initiatives • Mentor junior statistical programmers; provide technical guidance, code review, and professional development support • At the Senior Manager level, may manage 1–2 direct reports and provide input on hiring, performance, and team-building

🎯 Requirements

• 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 • 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