Abhijit Shete

WORK HISTORY

EDUCATION

ABOUT ABHIJIT SHETE

SAS/R professional with Statistical programming experience including extensive experience in all four phases ofclinical trials in pharmaceutical & CRO environment.• Experience supporting the programming activities for multiple clinical studies.• Thorough knowledge and experience in SAS BASE, MACRO, SQL, R (Admiral,Oak,rtables), ODS, GRAPH and STAT.• Created analysis datasets and generated Tables, Listings and Figures (TLFs) as per specifications and incompliance with FDA and other regulatory bodies.• Created Programming Specifications for ADaM datasets such as ADSL, ADLB, ADVS, ADTTE etc.• Created and performed validation of the Oncology SDTM domains such as TU, TR, RS, etc.• Derived responses according to the RECIST criteria to derive standard oncology endpoints such as progressionfree survival, overall survival and best overall response.• Created Kaplan Meier Curve for Progression Free Survival analysis using SAS/GRAPH and PROC TEMPLATE.• Developed analysis datasets with visit windowing, missing data imputations (LOCF, BOCF etc.) and datatransformations such as change from baseline, etc.• Created SAS Macros for reporting of statistical results using LIFETEST, LOGISTIC, and MIXED.• Strong experience in SAS ODS to extract data from SAS procedures and to create RTF and PDF output files.• Generated customized reports using standard company macros and Proc Report procedure.• Generated Ad-hoc reports to support requests from FDA, and other internal departments within the company.• Good knowledge and experience in MS Office tools, Software Development Life Cycle (SDLC), ICH guidelines.