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Statistical Data Management Professional
2 weeks ago
Clinical Programming Specialist: Job Description
The Clinical Programming Specialist is responsible for designing, implementing, and maintaining clinical trial data management plans, including case report forms, CRF annotations, SDTM, and ADaM datasets. The role requires strong analytical skills, excellent communication abilities, and the ability to work independently with minimal supervision.
Main Tasks:
- Annotate CRFs according to FDA/CDISC or sponsor guidelines.
- Develop and maintain SDTM and ADaM datasets using SAS.
- Create electronic submission packages for regulatory agencies.
- Collaborate with statisticians to interpret data and provide insights.
- Develop and maintain databases and systems to manage clinical trial data.
Requirements:
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or related field.
- Minimum 8-13 years of experience in Statistical Programming in Clinical domain.
