saurabh gupta

Working as a professional in a CRO company with a good experience and expertise.

• 3 Year of Experience in Clinical SAS programmer CDISC role.
• Develop SDTM specifications and generate SDTM datasets using SAS.          
• Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical
• Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Ensure datasets are error-free and comply with CDISC standards.
• Review logs to confirm successful execution of programs.
• Validate datasets against FDA rules and CDISC standards using Pinnacle 21 toolset.
• Perform Metadata file explaining dataset structure and content into Define.xml.
• Create data anomalies and derivation rule to describe into the Study Data Reviewer’s Guide. (SDRG) for SDTM and Analysis Reviewer’s Guide (ADRG) for ADaM.
• Submit data electronically in the eCTD format under Module 5Structure for Study Data.
• Analyse information and develop innovative solutions to programming and data analysis challenges.
• Actively communicate with statisticians for statistical input and analysis interpretation.
• Follow and reinforce regulatory agency requirements during daily job.
• Serve as a programming team and contribute to department initiative.
•  Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
• Review draft and final production deliverables for project to ensure quality and consistency.