Manager/Senior Manager, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, validate, and maintain SAS and R programs to generate CDISC-compliant SDTM and ADaM datasets, as well as tables, listings, and figures (TLFs) for clinical studies and regulatory submissions.

• Act as the lead programmer for designated Phase 2b/3 studies; create and review programming specifications, quality control plans, and define.xml files.

• Ensure that all deliverables are audit-ready and adhere to the statistical analysis plans (SAPs), protocols, and relevant FDA/EMA/ICH regulatory standards.

• Contribute to the development and upkeep of reusable SAS macro libraries, R packages, and programming best practices.

• Lead or assist in statistical programming tasks for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), clinical study reports (CSRs), and ad hoc regulatory inquiries.

• Ensure adherence to CDISC SDTM/ADaM implementation guidelines, the FDA Data Standards Catalog, and eCTD submission criteria; author and review Reviewer's Guides and define.xml documents.

• Review and provide feedback on electronic case report form (eCRF) designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans.

• Represent Statistical Programming during 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 outputs from CROs and external programming vendors.

• Contribute to or lead the development of departmental standard operating procedures (SOPs), work instructions, and process enhancement initiatives.

• Mentor junior statistical programmers; offer technical guidance, conduct code reviews, and support professional development.

• At the Senior Manager level, may supervise 1–2 direct reports and provide input regarding hiring, performance assessments, and team-building activities.

⛳️ Requirements

• Bachelor's degree in Statistics, Mathematics, Computer Science, or a related discipline; a Master's degree is preferred.

• 5–7+ years of statistical programming experience in the pharmaceutical, biotech, or CRO industries (Manager: 5+ years; Senior Manager: 7+ years).

• Advanced proficiency in SAS (Base, Macro, STAT, GRAPH) is mandatory.

• Comprehensive knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission criteria (FDA eCTD, define.xml, Reviewer's Guides).

• Demonstrated experience as the lead programmer on at least one late-phase (Phase 2b/3) clinical trial and/or regulatory submission.

• Strong understanding of Good Clinical Practices (GCP), ICH E3/E9 guidelines, and FDA/EMA data submission requirements.

• Exceptional attention to detail, communication abilities, and capacity to manage multiple projects and priorities simultaneously.

• Proficiency in R for statistical programming and reporting; familiarity with Python is a plus.

• Experience in supporting NDA/BLA submissions and addressing inquiries from health authorities.

• Familiarity with automation tools, version control (Git), and/or cloud-based programming platforms.

• Exposure to real-world evidence (RWE) datasets or adaptive trial designs.

• Experience in therapeutic areas related to pulmonary, respiratory, or rare diseases.

• SAS certification (Base, Advanced, or Clinical Trials Programming) is a plus.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.