Suresh S.

About Suresh S.

14+ years of experience of statistical programming in phase-I, phase-II, & …

Experience

1. Associate Principal i - Statistical Programmer

   Ephicacy Consulting Group Inc

   Oct 2023 — Present · Charlotte, NC, US

   SAS programming and analysis support for phase-I, phase-II & clinical trials.• Led multiple studies, new studies setup, planned timelines, and managed team, trained, guided, suggested, and drove team to deliver outputs with high quality within pre-defined timeframe.• Oversaw the creation and validation of SDTM and ADaM datasets for integrated summaries (ISS/ISE).• Developed & reviewed ‘Programming Data Specification’ for CDISC ADaM standard datasets & SDTM datasets.• Supported oncology studies in solid tumor, understood and implemented RECIST 1.1 criteria for CR, PR, PD, SD, Non-CR/Non-PD, time to event analysis, survival analysis, supportive analysis & sensitivity analysis.• Evaluated primary end point progressive free survival analysis and secondary end point overall survival analysis, objective response rate, clinical benefit rate, disease control rate, duration of response and time to response.• Programmed for Kaplan Meier tables & plots, forest, scatter, box, swimmer and water fall plots.• Implemented PROC LIFETEST & PROC PHREG to build regression models, log-rank P-value and hazard ratio.• Developed and validated SDTM trial design domains, oncology TU TR & RS domains & special purpose domains.• Developed and validated oncology ADaM datasets ADDATES, ADTTE, ADTR & ADRS.• Worked on efficacy & safety data for development of ADaMs(ADDATES, ADTTE, ADPC, ADPP & NONMEM, ADSL, ADLB, BDS, and OCCDS) & related reports.• Developed SAS programs from scratch for complex analysis datasets like NONMEM, POpPK, ADDATES, ADTTE, ADTR, ADRS, ADLB & etc.• Utilized SAS procedures FREQ, TTEST, LIFTEST, PHREG, GLM, MIXED & SGPLOT.• Used statistical tests t-test (paired t-test & unpaired t-test), chi-square test, fisher exact test, CMH test, risk diff, risk ratio/rel-risk & odds ratio.• Worked on comparison tables (regression model fitting like linear mixed models), EAIR tables, shift tables, change from baseline, percent change from baseline tables and effic

Education

• Kakatiya University, Warangal

  Bachelor's degree, Statistics

• Jobs in Warangal

  Bachelor of Science - BSc, Statistics

• Osmania University

  Master of Science - MSc, Statistics

• Kakatiya University, Warangal

  Bachelor's degree, Mathematics and Statistics