R Package Development (Statistical Monitoring)

Context: Global pharmaceutical company with 35,000+ clinical trial sites requiring scalable, automated statistical monitoring.

Challenge: Needed JMP‑equivalent R Shiny dashboards with advanced functionality – modals, accuracy measurement, logging, and automated report generation – to support 15–20 member study teams.

Solution: Developed production‑grade R Shiny applications using the Golem architecture, featuring:

• Interactive modals for drill‑down analysis
• Accuracy measurement and logging for audit trails
• Automated report generation in Excel and HTML formats
• Integrated with R Markdown scripts for adverse events (AE, SAE, BPD, OPD) and multi‑site visualization plots

Outcome: Replaced legacy JMP tooling with modern, maintainable applications scaling across 35,000+ sites, standardizing statistical monitoring and reducing manual effort.