The Statistical Programmer will lead key programming activities required for clinical trial data preparation, analysis, and reporting. The role requires expert-level hands-on programming experience, strong CDISC knowledge, and the ability to collaborate across teams while ensuring quality, accuracy, and compliance.
Key Responsibilities
- Perform statistical programming activities to support data analysis, interpretation, and regulatory submissions.
- Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards. Generate high-quality Tables, Listings, and Figures (TFLs) per SAP and study requirements.
- Prepare and maintain programming deliverables including dataset specifications, documentation, reviewer guides, and QC records.
- Mentor and train junior programmers; help elevate programming standards, workflows, and best practices.
- Collaborate across biostatistics, data management, clinical operations, and project management to ensure seamless execution of deliverables.
- May serve as Programming Lead on assigned studies.
- Experience as a statistical programmer within clinical trials (pharma, biotech, or CRO).
- Demonstrated proficiency in TFL programming. Strong command of CDISC SDTM and ADaM standards and submission practices.
- Experience preparing regulatory submission documentation and supporting data review.
- High attention to detail, structured communication style, and strong documentation discipline.
- Bachelor’s degree in statistics, computer science, life sciences, mathematics, or related field.
Technical Skills
- SDTM and ADaM dataset development and validation, TFL programming aligned with SAP and regulatory standards
- Define XML and submission documentation, including Pinnacle 21 and reviewer guides, QC processes, including double programming and traceability
- Knowledge of clinical trial data structures for safety and efficacy SAS programming: Advanced proficiency (Base SAS, Macros, PROC SQL, ODS).
- Familiarity with R for statistical computing and visualization (preferred but not required).
- Working knowledge of CDISC tools and associated validation frameworks.
- Experience using Jira, Confluence, or equivalent project management tools (preferred).
- Familiarity with Git or other version control systems.
- Experience working in a regulated environment (GxP, FDA, EMA submission settings).
- Comfort working in Windows and/or Linux command-line environments.
