Professional Summary
Between the clinical database and the regulator
I'm Shanu Rana — a Lead Statistical Programmer in clinical research.
Twelve years in pharma, nine of them programming the data behind clinical trials. I build and validate CDISC SDTM and ADaM datasets, the tables, figures and listings written against the Statistical Analysis Plan, and the submission packages — define.xml, Pinnacle 21, SDRG and ADRG — that carry a trial's evidence to health authorities. I lead studies from scope to submission across Phase I to III, setting the specifications and running the production and validation team. PMP and Advanced SAS certified, and extending the same discipline into R Programming.