About

Nilesh Borade

Senior Statistical Programmer and Early Phase Study Lead with 10+ years in regulated clinical data programming.

I work in GxP clinical data programming, building the CDISC pipeline from raw EDC data through SDTM and ADaM to TFLs and Define-XML. My career has run from a global CRO into sponsor-side early-phase work, where I now act as a study lead. Most of my delivery is in SAS and Python, across oncology (including RECIST), virology (HBV/HIV), cardiovascular, inflammation, and early-phase trials.

The tools on this site are work I designed and built myself, end to end — sole designer and developer of each one. They run inside locked-down, often air-gapped validated environments, which shapes every technical decision: local execution, no external services, and a clear audit trail.

My aim across all of them is the same: cut manual review effort, keep traceability intact, and give a programmer fast, trustworthy feedback before a deliverable reaches Pinnacle 21 or a sponsor.