Alka Purushotham

 Support programmer in creating and validating SDTM and ADaM datasets.  Writing Specs and creating PDS.  Writing SDRG and annotating CRF as per client standards.  Conducting frequent checks using Pinnacle 21 reports and adhering to the standard guidelines.  Direct involvement with the clients to get solutions for data discrepancies

 Interact with Clinical Data Management team to resolve data issues.  Generating CRT Packages and archiving studies.  Develop and validate various domain datasets as per GSK standards and CDISC standards.  Generate and validate Safety & Efficacy listings and Summary tables.  Use of SAS Sgplot for generating various Individual- Mean SD Plots, scatter plots and bar plots, for Pharmacokinetic and Pharmacodynamic populations.  Using Open CDISC Validator to review SDTM datasets.

 Exposure to Industrial Standard data and use of SAS tool.  Responsible for programming of datasets and TLFs in a Phase I study.

Clinical SAS