Gowri Sivakumar A

Experience

1. Statistical Programming

   Cytel

   Dec 2015 — Present · Hyderabad, IN

   Working experience on oncology therapeutic data for Sensitivity analysis, PRO analysis, Exploratory Analysis, Pooled Analysis.• Hands on experience on standardizing macros utilized in projects.• Working experience on HTA to create ADaM & TLFs.• Hand on experience in Phase I to Phase IV Clinical Trials and ICH GCP guidelines.• Good programming experience with SAS/Base (9.4), SAS/Macro, SAS/SQL & SAS/Graphs• Good understanding of FDA and CDISC guidelines Good Clinical Practice (GCP).• Worked on SDTM & ADaM dataset development and validation.• Advanced SAS programming and SAS procedures experience such as PROC SQL, PROC PRINT, PROC FREQ, PROC FORMAT, PROC TRANSPOSE, PROC COMPARE, PROC MEANS, PROC SORT, PROC IMPORT, PROC REPORT and PROC EXPORT.• Excellent knowledge in merging SAS datasets, Macro facility, SAS Formats, SAS Functions, storing and managing data in SAS files.• Good domain knowledge like Demographic Data, Adverse Events (AE), Concomitant medication (CM), Laboratory (LB Data), as per SDTM standards.• Having knowledge & can prepare scripts to ensure data access, manipulation & reporting functions with R programming languages.• An impelled individual with ability to analyze, organize, communicate and work as a team.

Education

• Sikkim University, Gangtok

  Master’s Degree

• Annamalai University

  Bachelor’s Degree