- Ability to critically understand and review various study documents such as eCRFs, protocol, specifications and Statistical Analysis Plan (SAP).
- Ability to create and review CRF annotations and specifications using raw data, protocol and SAP.
- Comprehensive knowledge about creating SDTM datasets using CDISC SDTMIG, Raw datasets and other client documents such as Protocol and Statistical Analysis Plan (SAP).
- Capable of creating TLFs using ADaM datasets and validating with the respective mock shell as per client requirements.
- Competent in working on both the production and validation sides for SDTM and ADaM datasets.
- Perform all required clinical SAS related programming tasks as required by client. Need to possess end to end knowledge about SAS programming encompassing SDTM, ADaM, TLF.
- Good understanding of SAS macros creation and its uses in data manipulation.
- Competent in working with Pinnacle 21 issues, define.xml SDTM Reviewers Guide (SDRG) and ADaM Reviewers Guide (ADRG).
- Capable of working independently and troubleshoot programming issues as required by client.
- Base and Advanced SAS programming
- SDTM
- ADaM
- Tables, Listings, Figures/Graphs
Job Type: Full Time
