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Senior Statistical Programmer
vor 3 Monaten
Key responsibilities and skills may include, but are not limited to:
- Annotate Case Report Form ) following FDA/CDISC or sponsor guidelines.
- Develop SDTM specifications and generate SDTM datasets using SAS.
- Develop ADaM, specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
- Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
- Develop ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
- Create an electronic submission package to FDA, e.g., or following FDA guidelines with minimum supervision.
- Analyze information and develop innovative solutions to programming and data analysis challenges.
- Actively communicate with statisticians for statistical input and analysis interpretation.
- Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives.
- Provide guidance, mentoring, training for team members and help solve issues from crossfunctional teams.
- Review draft and final production deliverables for project to ensure quality and consistency.
Qualifications
Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or related scientific disciplines with at least 3 years of clinical programming experience.
Job Type:
Contract
Pay: 40,00€ - 60,00€ per hour
Expected hours: 40 per week
