Vaisakh Pattathil

Creation and validation of SDTM & ADAM datasets, tables, figures and listings (TFL), including statistical analyses. Create/review programming plan, specifications for datasets and TLFs. Create/acquire tools to improve programming efficiency or quality Validate work of other programmers. Understand, own and author the programming specifications and database definitions.

Leading projects and involved in project work independently. Generating ADAM datasets, tables, figures and listings (TFL), including statistical analyses. Perform Stage 1 and 2 Quality Control (QC) as per GSK QC guidelines. Participating in Internal Stage 3 QC. Maintaining QC spreadsheet as per GSK SOP processes. Review and Input into key documents (eg: Protocol, CRF, SDTM Spec, RAP and Statistical reports).

Creating SDTM datasets , Reviewing CRF and creating SDTM Specifications. Creating Tables, Listings & Figures (TLF) from ADAM datasets. Analysis and reconciliation of huge data’s using SAS programming (eg: LAB, PK, ECG, SAE etc).

Develop clinical data programs per specification (SAS Edit check programming). Validate clinical data programs per the formal, documented QC process. Execute programs and generate data outputs according to study/client requirements (SAS Reports)

Develop clinical data programs per specification (SAS Edit check programming). Assist in designing, testing and maintenance of Clinical databases. Perform scheduled day to day program re-run and deliver outputs (SAS Reports).

• Handling background verification for Hireright US. • Handling customer quires. • Coordinate work between internal teams. • Verifying customer background based on US laws.

Creating tables, listings & graphs using SAS as per Specification