Manager of Statistical Programming

Position Summary

The Manager of Statistical Programming is responsible for delivering study-level programming deliverables and milestones. The role combines hands-on programming in SAS and R with oversight of a small team or of CRO programmers assigned to a study.

The position requires working knowledge of statistical programming languages and software, clinical trial data, and the drug development process. The incumbent develops and oversees programs that generate CDISC-compliant SDTM and ADaM datasets, TLFs, and reports supporting the review of clinical data. The incumbent also writes validation programs and general-purpose code, prepares documentation to support electronic submissions, and contributes to programming standards and templates.

Responsibilities

• Plans and delivers statistical programming for assigned studies in support of clinical trials, regulatory submissions, publications, and ad hoc analysis requests, following applicable regulatory guidelines and standards.
• Tracks programming timelines for assigned studies and flags risks to the Director so deliverables stay aligned with the study schedule.
• Creates or oversees the creation of CDISC-compliant SDTM and ADaM datasets, and performs conformance checks (e.g., Pinnacle 21) before delivery.
• Develops and validates TLFs and analysis datasets using SAS and R; performs independent QC of programming produced by others, including cross-language validation where appropriate.
• Assigns and reviews the work of a small team of internal programmers and/or CRO programmers; provides day-to-day direction, feedback, and mentoring.
• Reviews CRO deliverables, specifications, and documentation for quality and standards compliance, and escalates issues as needed.
• Participates in study meetings with Clinical Operations, Data Management, Safety, and Biostatistics to develop specifications and reports.
• Writes and maintains batch scripts to schedule SAS and R jobs and distribute reports to the clinical team.
• Prepares programming documentation supporting electronic submissions, including define.xml inputs and reviewer guide content.
• Contributes to the development of SAS macros, R functions, standards, templates, and SOPs, and to cross-functional initiatives.
• Provides input on programming tools and infrastructure needs, including SAS and R environments, and works with IT as needed.

Qualifications

• BS/BA in Statistics, Computer Science, Mathematics, Life Sciences, or a related field; MS preferred.
• 8+ years of statistical programming experience in pharma, biotech, or CRO with a BS, or 6+ years with an MS.
• 1–2 years of experience supervising programmers or serving as lead programmer on a study.
• Strong SAS skills (Base, Macro, SQL, STAT, ODS/Graph).
• Working proficiency in R for clinical data manipulation, analysis, and reporting (e.g., tidyverse, admiral, gt, rtables, or similar).
• Experience developing R Shiny applications for interactive data review, safety monitoring, or visualization of clinical trial data is a plus.
• Working knowledge of CDISC SDTM and ADaM, controlled terminology, and Define-XML.
• Familiarity with ICH guidelines and GCP; exposure to a regulatory submission is a plus.
• Experience with Python for automation, data processing, or tooling is a plus.
• Clear written and verbal communication; comfortable working directly with statisticians and clinical teams.