Harish K

About Harish K

Developed eCRT (define.xml) packages for both SDTM and ADaM datasets, ensuring full compliance with FDA and PMDA submission standards using P21E validation tools.eSubmissions & Regulatory Data Standards Expertise.Created comprehensive Clinical Study Data Reviewer\'s Guides (cSDRG) and Analysis Data Reviewer\'s Guides (ADRG) to facilitate regulatory review processes.Managed end-to-end clinical programming responsibilities across multiple therapeutic areas, including Oncology, Neuroscience, and Cardiovascular.Provided hands-on programming expertise for ISS/ISE (Integrated Summaries of Safety/Efficacy) studies, including the development of required eCRT submission packages.Leveraged comprehensive SAS programming skills throughout the entire clinical data lifecycle, from data manipulation to analysis and reporting.

Experience

1. Principal Statistical Programmer

   Takeda

   Apr 2024 — Present · Boston, MA, US

   Regulatory Submissions & Clinical Data Standards Expertise- Led the development of eCRT packages (SDTM & ADaM) for regulatory submissions to FDA and PMDA- Contributed to ISS/ISE eCRT packages and performed comprehensive reviews ensuring compliance with submission standards- Acted as Subject Matter Expert (SME) in ARM development, creating ARMs across multiple studies- Extensively authored cSDRG and ADRG documents for individual studies as well as ISS/ISE submissions- Developed analysis datasets for ISS/ISE studies and supported creation of ISE efficacy tables- Strong expertise in define.xml creation using P21E v2.0 and v2.1, including linking submission‑ready analysis datasets and TLF programs per 2.1 standards- Reviewed aCRFs and submission programs during eCRT package preparation- In‑depth knowledge of M5 submission folder structures, P21 dataset validation issues, and regulatory guidelines (SDTM MSG v2.0, ADaM MSG v1.0, FDA Technical Conformance Guide)

Education

• Harrisburg University of Science and Technology

  Masters, Computer Science