Shanu Rana

Statistical Programming

LinkedIn Verified Credentials
Shanu Rana, Lead Statistical Programmer
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.

12+Years in pharma & clinical research
9+Years in statistical programming
PMPCertified
SASBase & Advanced certified

Toolbox

Programming

  • SAS — Base & Advanced (certified)
  • R — Tidyverse, pharmaverse

Leadership & Delivery

  • Project management (PMP)
  • Studies lead
  • Teams of programmers
  • Dual-programming validation
  • Client & scope management
  • Mentoring & SME training

Standards & Submission

  • CRF annotation
  • CDISC SDTM
  • CDISC ADaM
  • define.xml, Pinnacle 21
  • SDRG, ADRG, CRT

Systems & Process

  • Deliverables trackers
  • QC checklists
  • Internal SOPs

Clinical Domain

  • Oncology — solid tumours (RECIST 1.1)
  • Phase I–III trials
  • SAP & TFL shells
  • ICH-GCP

Languages

  • Hindi — mother tongue
  • English — fluent, written & spoken
  • German — basic

Certifications

Education

Get in touch

I'm always open to expanding my professional network — do reach out if our work overlaps.

Connect on LinkedIn
Away from the data

I photograph wildlife, landscapes and the road in between. That half of the story lives on its own site.

Photography & Travel