Principal Statistical Programmer

Overview

Principal Statistical Programmer - Remote Europe OR LATAM

Responsibilities

Technical Programming Leadership

• Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation.
• Program complex Tables, Listings, and Figures (TLFs) for study reports, publications, and submissions.
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code.

Project & Study Support

• Serve as lead programmer on multiple studies and/or projects, coordinating efforts across internal teams and CROs.
• Provide technical oversight and mentoring to junior programmers and contractors.
• Collaborate closely with Biostatistics, Data Management, and Clinical teams to deliver timely and accurate outputs.

Standards & Compliance

• Ensure programming deliverables comply with industry standards (CDISC, FDA, EMA) and internal SOPs.
• Contribute to the development and implementation of programming standards and reusable code libraries.
• Participate in quality control, peer review, and validation of programming deliverables.

Submission & Regulatory Support

• Prepare and review submission ready datasets, define.xml files, and reviewer guides for regulatory authorities (e.g., FDA, EMA).
• Support integrated summaries of safety (ISS) and efficacy (ISE) analyses for NDA/BLA/MAA submissions.
• Use tools such as Pinnacle 21, OpenCDISC, and define.xml generators to ensure submission compliance.
• Performs other duties as assigned
• Complies with all policies and standards
• Bachelor's Degree Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field. Required or
• 7-9 years in statistical programming within the pharmaceutical, biotech, or CRO industry. Required
• Expert level proficiency in SAS Base, SAS Macro, and SAS SQL. High
• In depth experience with CDISC SDTM and ADaM standards. High
• Proven track record of supporting clinical trial reporting and regulatory submissions. High
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA and EMA regulatory expectations. High
• Excellent problem solving skills and attention to detail. High
• Strong communication and collaboration skills. High
• If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.