Sriram Venkatachalam
Lynnwood,WA
Summary
Diligent SAS certified professional Programmer with solid background in statistical programming. Proven ability to develop and implement statistical models that drive impactful data insights. Have a keen eye for data errors and have the knack for catching issues at early phase of the the study. Demonstrated proficiency in SAS, with strong focus on analysis and data validation.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Principal Statistical Programmer
Fortrea [Formerly LabCorp]
09.2023 - Current
- Lead SDTM, ADAM and TLF deliverables for publications and submissions with FDA
- Provide inputs to manager and leadership team in deciding on timelines for various submissions
- Review SAP and TLF shells from programming perspective and share feedback with statisticians and cross functional teams, and then update ADAM specs accordingly
- Train new colleagues and delicate programming assignments to the team and track progress
- Write specifications for SDTMs and ADAMs, and communicate complex derivations to programming team effectively
- Write robust study level macros to facilitate consistent and reliable production of outputs and datasets
- Perform quality checks at various stages to ensure high quality outputs
- Develop and maintain SAS programs to create SDTM and ADAM, and perform QC of the same
- Summarize changes in database, if any, to programming team and make sure all data are appropriately mapped into respective domains and datasets
- Review data issues log and communicate data issues to Data Management and External datasets handling team and follow up status of all queries raised
Senior Statistical Programmer
LabCorp Drug Development [Formerly Covance]
08.2020 - 08.2023
- Wrote SDTM, ADAM specifications and annotated CRF for SDTM creation
- Wrote SAS code to create SDTMs, ADAMs, tables, listings and figures
- Generated define XML/PDFs through Pinnacle 21 Community and Pinnacle 21 Enterprise, and annotated CRFs and wrote reviewer's guide for SDTMs and ADAMs
- Reviewed and annotated table & listing shells to enable consistent and smooth production of outputs
- Performed version controls of all deliverables through CVS, and performed high level cross validation between Final and Development area to ensure high quality outputs are delivered
- Wrote SAS programs to create patient profiles that also clearly show cased changes in the database between current run and previous run
- Logged in all data issues in Data Issues Tracker and followed up with cross functional teams about their status
Statistical Programmer/Analyst - II
Covance [Formerly Chiltern]
04.2017 - 07.2020
- Annotated CRFs with SDTM variables
- Worked on SDTMs specification
- Wrote SAS programs to generate SDTMs, ADAMs and Tables and Listings
- Responded to QA and internal quality check audits with support of senior programming staff
- Logged in all data issues
- Wrote SDTM level macros to facilitate consistency is the derivation of SDTM variables
Statistical Programmer - Contractor
Seattle Genetics
02.2016 - 04.2017
- Created and validated SDTM, ADaM and TLFs as part of drug safety analyses for Safety Monitoring Committee (SMC) and CSR
- Developed ISAFE datasets
- Wrote and modified SDTM and ADaM specs and annotated CRF
Volunteer Research Assistant
Human Performance Institute - UTA
10.2013 - 02.2016
- Conducted reliability tests by determining Cronbach's alpha, interclass correlation and Pearson's correlation coefficients and applied statistical procedures to evaluate for memory & practice effects
- Applied Non-linear Causal Resource Analysis to evaluate RC21X performance measures' consistency with General Systems Performance Theory's hierarchical relationship and also to detect the subjects' brain performance limiting resources
Education
M.S. - Biomedical Engineering
University of Texas Arlington
08.2015
B.Tech - Electronics & Instrumentation Engineering
Amrita Vishwa Vidyapeetham
06.2013
Skills
- Descriptive and inferential analysis
- Statistical analysis
- Clinical SAS programming
- CDISC Standards
- Data management
- SAS/Base
- SAS/STAT
- SAS/SQL
- SAS/MACRO
- SAS/ODS
- SAS/GRAPH
- SAS Enterprise Guide
- MS Excel
- Data Cleaning
Databases
Inform
Veeva
Excel
Certification
- SAS Certified Advanced Programmer for SAS 9, AP013718v9
- SAS Certified Base Programmer for SAS 9, BP047937v9
- Many Statistics and Data Science courses from Coursera
Timeline
Principal Statistical Programmer
Fortrea [Formerly LabCorp]
09.2023 - Current
Senior Statistical Programmer
LabCorp Drug Development [Formerly Covance]
08.2020 - 08.2023
Statistical Programmer/Analyst - II
Covance [Formerly Chiltern]
04.2017 - 07.2020
Statistical Programmer - Contractor
Seattle Genetics
02.2016 - 04.2017
Volunteer Research Assistant
Human Performance Institute - UTA
10.2013 - 02.2016
B.Tech - Electronics & Instrumentation Engineering
Amrita Vishwa Vidyapeetham
- SAS Certified Advanced Programmer for SAS 9, AP013718v9
- SAS Certified Base Programmer for SAS 9, BP047937v9
- Many Statistics and Data Science courses from Coursera
M.S. - Biomedical Engineering
University of Texas Arlington
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