Role: Lead Developer | Duration: 12 months | Regulatory Focus: FDA/EMA Compliance
Project Overview:
Designed and built an end-to-end reporting system for clinical trials that takes raw data all the way to submission-ready reports. It produces SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model) and TLG (Tables, Listings, and Graphics) outputs in line with CDISC standards, and generates the Clinical Study Report (CSR) automatically.
Key Achievements:
• Cut report generation from 6 weeks to 2 days (95% time savings)
• Reached 100% CDISC compliance through automated validation checks
• Added version control and audit trails for regulatory transparency
• Processed multiple studies in parallel, reducing resource bottlenecks by 80%
Technical Architecture: R (statistical computing), R Markdown (reports), SAS (legacy integration), GitLab CI/CD (automation), Docker (containers), Linux (deployment)