Prasanth Reddy Kondapalli

Developed and maintained SAS programs for clinical trial data analysis, SDTM/ADaM dataset creation, and TLF generation in compliance with CDISC and regulatory standards. Managed end-to-end clinical programming activities, including data validation, discrepancy resolution, quality checks, and preparation of submission-ready outputs for global regulatory agencies. Collaborated with biostatisticians, clinical data managers, and cross-functional teams to deliver accurate statistical reports, streamline workflows, and support timely study milestones. Automated reporting and data processing tasks using SAS and SQL, improving operational efficiency, reducing manual effort, and enhancing data accuracy across multiple clinical studies. Supported multiple Phase I–IV clinical trials across diverse therapeutic areas while ensuring adherence to FDA, EMA, GCP, and organizational compliance requirements.

Developed and maintained SAS programs for clinical trial data analysis, SDTM/ADaM dataset creation, and TLF generation in compliance with CDISC standards. Performed data validation, quality checks, and discrepancy resolution to ensure accuracy, integrity, and regulatory readiness of clinical datasets. Collaborated with biostatisticians, clinical data managers, and cross-functional teams to support study deliverables, regulatory submissions, and database lock activities. Automated reporting processes and optimized programming workflows, improving efficiency, reducing manual effort, and ensuring timely project delivery. Supported global clinical studies across multiple therapeutic areas while ensuring compliance with FDA, EMA, GCP, and industry regulatory guidelines.