Statistical Programmer, India
Posted Updated 5
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Summary
Build and validate clinical trial datasets (SDTM/ADaM) and tables/figures using SAS, ensuring regulatory compliance for pharmaceutical research.
- Create SDTM defineXML and ADaMs defineXML
- Develop SDTM and ADaM reviewer guides
- Develop maintain validate SDTM ADaM and TLF specifications
- Develop maintain validate annotated case report forms aCRFs
- Ensure compliance with ICH guidelines and regulatory requirements
- Perform statistical programming for SDTM ADaM derived datasets and TLFs
- Review programming scope identify out of scope tasks
- Support data management with data cleaning programming and reporting
- Use global SAS macros to improve programming efficiency
- Validate SDTMs and ADaMs using Pinnacle 21
Perks/Benefits:
- Flexible schedule
- Home-based position
- Ongoing learning and development