- Create primary statistical programming to generate deliverables in accordance with TFL shells, programming instructions, and programming dataset specifications.
- Validate deliverables to ensure correctness, completeness, and compliance with internal and external standards.
- Create study, project, or global macros to support repeatable and efficient programming workflows.
- Contribute to the development and review of programming dataset specifications and related documentation.
- Ensure quality and timely completion of deliverables; manage multiple tasks to meet delivery timelines and escalate issues as needed.
Skills Required:
- At least 3 years of relevant statistical programming experience in the pharmaceutical or device industry.
- Experience with SDTM and ADaM (including statistical programming deliverables aligned to standards).
- Robust TFL (Tables, Listings, Figures) programming experience using TFL shells and programming dataset specifications.
- Ability to validate deliverables and ensure quality/timeliness to support audit readiness.
- Experience creating and maintaining study/project/global macros and contributing to SP standards and processes.
Good to Have
- Experience with ADSL, ADVS, ADQS, and ADLB datasets.
Education: Relevant degree in a scientific/technical discipline