PRASANTHI PALLAPOTHU

• Over 10+ years of Strong SAS programming experience with extensive knowledge involving all phases of clinical trials • Strong working knowledge with analysis of clinical trial data, generating reports as per company standards in compliance with CDISC and other FDA and GCP Guidelines for Phase (I- IV) Clinical Trial studies. • Strong experience of CDISC analysis data model (ADaM) and Study Data Tabulation Model (SDTM). • Possess sound knowledge of SAS-Base, SAS-Advanced and SQL • Strong experience of safety and efficacy reporting. Understanding of clinical data life cycle from data collection to submission. • Strong working knowledge on programming for ADaM data structures as well as creation of Specifications. • Extensive programming ability including programming safety, efficacy to generate tables, listings and Figures. • Knowledge of eSubmission processes and define.xml. • Programming for CDISC SDTM development and validation. • Experienced in Specification creation and development of Analysis datasets (CDISC ADaM data structures) • Strong SAS programming skills, with proficiency in SAS/Base, SAS/SQL, SAS/Stat and SAS Macros. • Sound Knowledge on RECIST criteria (overall response). Target lesions and Non-target lesions • Profound knowledge on PROC LIFETEST and generating KM Plots. • Developed oncology SDTM datasets such as TU, TR, and RS datasets as per RECIST1.1 on solid tumor assessments. • Exclusively worked on End Points of Oncology study PFS (Progression Free Survival), OS (Overall Survival). • Expertise in creating Tables and Listings for ISE and ISS. • Good knowledge on STAT procedures PROC GLM, MIXED, REG, ANOVA, LIFTETEST, PHREG procedures. • Experience in using different R functions like Mutate, Pivot_wide, Pivot_long, arrange, alter, select, full_join, left_join, right_join, anti_join, toupper, tolower, slice (), slice (), rename, case_when, bind_rows, anti_join, cross_join, summarize and count. • Working Experience on R packages like Tidyverse, Dyplr, haven, Admiral, lubridate, waldo and labelled.