Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

SRINI Gunnam

Mississauga,ON

Summary

  • Certified BASE SAS Programmer with around 5 years of experience with Clinical trials, SAS tools and Statistical analysis with emphasis on clinical data analysis, data validation and statistical report generation.
  • Worked closely with Statisticians on Primary and Secondary endpoint analysis and reporting for Oncology and CNS studies.
  • Expertise in SAS STAT procedures and MACRO programming.
  • Expertise in SDTM clinical terms and clinical development processes.
  • Expertise in creation of SDTM and ADaM specifications and programming for Phases I, II and III studies.
  • Working experience in integration of studies for ISS and ISE and involved in Mapping, Analysis and Reporting.
  • Familiarity with ICH, GCP guidelines and Electronic Submission standards.
  • Thorough knowledge of Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE), Laboratory data and Safety and Efficacy related data.
  • Generating Safety and Efficacy tables, data listings and graphs Extensive experience in working on Efficacy endpoints with Time to Event Analysis, ANCOVA modeling, Mixed modeling, Logistic analysis, Categorical Analysis etc.
  • Performed Cleaning Techniques, QC Validation and Edit Checks as per protocol designs on Clinical Data Extensive experience in working on CDISC, SDTM 3.1.2/3.1.3/3.2 IG and ADaM 1.1/1.2 Standard, Define.xml Creations, CRTs.
  • Developed reports using PROC REPORT · Worked closely with Statisticians, data managers and medical writers.
  • Also, involved in visit Windowing, missing data handling using LOCF, BOCF, WOCF concepts and written analysis files specifications for various therapeutic areas.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Sr. SAS Programmer

Clinchoice
02.2021 - Current
  • Working as a contract senior SAS Programmer, focused on Oncology (solid tumor) and Vaccines therapeutic areas.
  • Acted as study Lead for 8 studies and responsible for timelines preparation, Work allocation and meet all deliverables on time with high quality.
  • Provided SAS programming and analysis support for phase II & III oncology studies with NSCLC and SCLC indications.
  • Worked on creation of SDTM mapping specifications following define compliant template. Worked on open CDISC validator (Pinnacle21) and addressed the issues.
  • Skilled in Oncology Domains like Tumor Identification (TU), Tumor Response (TR) and Disease Response (RS) and analysis datasets like ADPSF, ADRS and ADTTP according to specifications as per CDISC standards (SDTM & ADaM), evaluated solid tumor response using RECIST 1.1 and IRECIST.
  • Created Case Report Tabulations (CRT) Datasets for FDA Submissions ensuring that all variables adhere to CDISC Standards.
  • Developed standard macros for SDTM and ADaM programming based on computational Methods. Involved in creation of ADaM specifications using SAP and ADaM Implementation Guide v1.1.
  • Involved in Development and Validation of Analysis datasets as per ADaM 1.1 standards and produced the tables, listings and graphs as per specifications and mockups.
  • Involved in programming and QC of the efficacy, safety tables, listings and figures. Worked on ad-hoc requests supporting Statisticians and Clinical team.

Jr. Statistical Programmer

Phastar
01.2019 - 02.2021
  • Worked on ISS and ISE for 20 studies integration of CNS compound
  • Involved in end-to-end activities from SDTM Mapping till eSub package creation
  • Have used P21 tool in checking compliance and creation of Define.xml for both SDTM and ADaM datasets
  • Worked closely with Statisticians on Primary and Secondary endpoint analysis and reporting for Oncology studies
  • Drafted Specs and involve din programming of Oncology Efficacy datasets like ADTR, ADRS and ADTTE and generated the TTE outputs and Best overall Summary reports
  • Reviewed protocols, case report forms, SAP, Shells and Define.xml
  • Worked on SDTMs high level review and helped client as being point of contact for package review
  • Used SAS Macros in creation of new programs as well as modification of existing programs
  • Involved in Safety and Efficacy TFL generation based on existing macros and developed from scratch programming
  • Created Oncology specific graphs like KM plot, Waterfall plot, Spyder plot, Swimmerlane plot and Forest plots.

SAS Programmer

Bioclinica India Private Limited
04.2017 - 04.2018
  • Supported CNS, CVS, Oncology solid tumor and Pain management studies
  • Reviewed protocols, case report forms, statistical analysis plans for clinical trials
  • Pooling safety and efficacy studies to generate ISS/ISE for regulatory submissions
  • Extensively worked on CRF annotations and creating SDTM datasets
  • Experience in working on open CDISC validator (Pinnacle21) and address issues
  • Worked on different Oncology Domains like Tumor Identification (TU), Tumor Response (TR) and Disease Response (RS) as per CDISC standards (SDTM & ADaM)
  • Extensively worked on creating ADaM datasets like ADSL, BDS (ADRS, ADTTE, ADLB, etc.) from SDTM mapped datasets following ADaM Implementation Guide V1.0
  • Performed statistical data analysis and contributed to creation of Tables, Listings and Graphs (TLG) for internal purposes and for FDA submissions using SAS
  • Involved in programming and QC of efficacy, safety tables, listings, and figures
  • Created Case Report Tabulations (CRT) Datasets for FDA Submissions ensuring that all variables adhere to CDISC Standards
  • Developing SAS code according to design specifications and Produced tables, listings and graphs for final FDA study submissions
  • Worked closely with statisticians and clinical researchers to review clinical data for FDA submission and prepared documentation for team review including data specifications and validation summary
  • Used SAS Macros in creation of new programs as well as modification of existing programs.

Education

Master of Science - Computer Science

Cegep De La Gaspésie Et Des Iles
Montréal, QC
08.2019

Bachelor of Science - Computer Science

PB Siddhartha College of Arts & Science
VIJAYAWADA
03.2017

Skills

  • SAS, CDISC, Efficacy, Oncology, Non-Oncology like CNS, CVS, Immunology Vaccines, etc, RECIST, CTCAE, Lead Experience, ISS/ISE, Documentation review like SAP/Protocol/CRF/Shells etc, eSubmission Package creation with SDRG/ADRG/Definexml components

Certification

Certified Base Programmer for SAS 9

Timeline

Sr. SAS Programmer

Clinchoice
02.2021 - Current

Jr. Statistical Programmer

Phastar
01.2019 - 02.2021

SAS Programmer

Bioclinica India Private Limited
04.2017 - 04.2018

Master of Science - Computer Science

Cegep De La Gaspésie Et Des Iles

Bachelor of Science - Computer Science

PB Siddhartha College of Arts & Science
SRINI Gunnam