kovvurisushmitha naidu
@kovvurisushmithanaid
Statistical programmer specializing in clinical data and CDISC standards.
IndiaWhat I'm looking for
I am a statistical programmer with three years of focused experience in clinical data analysis, statistical modeling, and SAS programming. I specialize in mapping and validating clinical datasets to CDISC standards (SDTM 3.4), creating ADaM analysis datasets, and producing tables and listings to support regulatory submissions.
I have hands-on expertise with CRT packages (Define.xml, CSDRG, ADRG, submission-ready aCRF), CRF annotation, Pinnacle21/OpenDISC validation, and familiarity with ICH/GCP guidelines. I collaborate closely with statisticians and cross-functional teams to deliver reproducible, high-quality results under tight deadlines.
Experience
Work history, roles, and key accomplishments
Statistical Programmer
Eli Lilly and Company
Jun 2022 - Present (3 years 4 months)
Develop and validate SDTM and ADaM datasets and generate tables/listings for multiple clinical trials, ensuring CDISC and ICH/GCP compliance and regulatory-ready deliverables.
Education
Degrees, certifications, and relevant coursework
OUOsmania University
Master of Pharmacy, Pharmacy
2021 -
Pursuing Master of Pharmacy at Osmania University focusing on advanced pharmaceutical sciences and research skills.
OUOsmania University
Bachelor of Pharmacy, Pharmacy
2017 - 2021
Completed Bachelor of Pharmacy with foundational training in pharmaceutical sciences and clinical applications.
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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