Statistical Programmer, India
Tasks
- 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
Skills/Tech-stack
ADaM | CDISC | Clinical Data Interchange Standards | Clinical Data Interchange Standards Consortium | Clinical data | Data submission | DefineXML | Drug development | Electronic Data | Electronic data submission | Good Clinical Practice | Good Clinical Practice (GCP) | ICH Guidelines | Pinnacle 21 | Quality Control | SAS | SAS Macro | SDTM | Statistical Analysis | Statistical Analysis Plan | Statistical Analysis Plan (SAP) | TLF | XML
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Roles
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