Sivaprakash Kumarasamy

- Project planning and execution and quality of the deliverable - Work closely with Statisticians, Data managers, medical writer and support study team - Review, give inputs to trial related documents CRFs, data validation checks, Statistical programming shells, programming/analysis data specification - Metadata set-up, creating/validating analysis data sets to have all derive variables ready for report developments. - Development validation of tables, listing, graphs.

- Responsible for Creating the Safety, PD and PK TFL’s as per Clients protocol and specifications. - Worked as Support programmer and Trial programmer which give the responsibility of leading study - Responsible for approving for Database setup, CRF designing & discussions - Validation plan creation for the trial with Data management and other Stake holders. - Worked on client specific CDW systems which help to generate datasets from OC data - Developed and Validated the Macro’s for TFL’s.

- Develop/Validate the Analysis dataset as per the requirement specification - Develop/Validate the Safety table, listing as per the Mock Shell - Discuss the project related queries/clarifications with study statistician - Responsible for debugging and customising the study specific macros - Created SDTM datasets (version 3.1.2) for standard and custom domains from Raw Data sets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide

- CDISC ADaM conversion and validation. - CDISC ADaM Define.xml subject matter expert. - CDASH Implementation in EDC systems. - Protocol / Statistical analysis plan (SAP) - Statistical Programming - analysis datasets - Statistical report - tables, figures and listings - Statistical consultancy and statistical training. - Clinical database setup and data validation checks