vom 19.03.2026
The Programming Lead is responsible for providing oversight and ensuring deliverables align with the client's requirements.
Responsibilities: Provide oversight of outsourced statistical programming deliverables, including SDTM, ADaM datasets and Tables, Listings, and Figures, ensuring compliance with internal standards and regulatory requirements. Perform technical review and quality oversight of vendor programming outputs, including datasets, derivations, specifications, and analysis programs. Ensure timely delivery of study milestones, including interim analysis outputs and final study report deliverables. Coordinate with statisticians, internal teams, and external programmers to clarify specifications, resolve issues, and ensure alignment across programming activities. Support data review and transfer activities within EU-restricted systems, including entimICE and LSAF environments.
Requirements: Extensive experience in clinical statistical programming in the pharmaceutical or biotech industry. Strong expertise in CDISC standards (SDTM and ADaM) and generation/review of TFLs. Proven experience in programming lead or vendor oversight roles managing outsourced programming deliverables. Advanced programming skills with the ability to review complex programs and derivations. EU-based with the ability to review study data within EU-restricted environments due to patient data transfer limitations.
Please keep in mind that this is a Contractor/Freelance position of approx. 10h per month.
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