Kushagra K.

About Kushagra K.

Over 10 years of experience as a Statistical Programmer specializing in SDTM and ADaM standards.* Delivered statistical programming leadership for 25+ Phase clinical trials across multiple therapeutic areas, including oncology, with FDA submissions (CSDRG, ADRG, define.xml) that passed review without major findings.* Directed programming deliverables for blinding/unblinding and database locks, safeguarding trial integrity and meeting all submission timelines.* Developed and validated CDISC-compliant SDTM and ADaM datasets (ADSL, ADAE, ADLB, ADVS, ADRSP, ADTTE) and generated TLFs for CSR, ISS, and ISE in compliance with FDA, PMDA, and EMA standards.* Applied advanced SAS programming (data steps, macros, PROC SQL, ODS, PROC TEMPLATE) and integrated R/Python to produce statistical analyses and visualizations (Kaplan–Meier, Forest, Waterfall, Spider, Swimmer plots) supporting efficacy and safety evaluations.* Authored and reviewed submission deliverables including CSDRG, ADRG, define.xml, and dataset specifications; performed compliance checks using Pinnacle 21 (community & enterprise).* Optimized programming workflows, reducing work hours for deliverables and improving QC accuracy across multiple projects.* Led cross-functional collaboration with statisticians, data managers, and clinical teams to align data structures, resolve data issues, and accelerate study delivery.* Mentored and trained junior programmers, standardizing best practices and improving productivity in multi-study environments.* Maintained programmatic traceability from source data to analysis outputs, ensuring reproducibility, audit readiness, and compliance with SOPs and regulatory requirements.

Experience

1. Lead Statistical Programmer

   Merck

   Sep 2024 — Present · Rahway, NJ, US

Education

• Pune University

  Bachelor of Science - BS

  2005 — 2009

• Long Island University

  Master of Science - MS, Industrial Pharmacy and Pharmacology Studies

  2010 — 2012