Statistical Programmer II

Overview

Statistical Programmer II with experience supporting multiple clinical studies by developing, validating, and delivering statistical programming outputs. Works across SAS-based SDTM/ADaM and regulatory submission deliverables, with ability to use R and AI tools to enhance programming.

What you'll do

• Develop specifications and SAS programs for SDTM datasets and clinical analysis deliverables.
• Create specifications and SAS programs for ADaM datasets for trial reporting and integrated safety/efficacy analyses.
• Develop, maintain, and validate Tables, Listings, and Graphs (TLGs) based on biostatistical requirements and SAPs.
• Program and QC data listings, summaries, graphs, and statistical models.
• Design and maintain reusable SAS macros for Phase I–IV clinical trial reporting.
• Generate submission-ready datasets and outputs using industry standards and regulatory requirements.

What you'll need

• Minimum 4–5 years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred.
• Advanced SAS programming expertise including data extraction, integration, analysis, reporting, and automation.
• Proficiency in Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
• Knowledge of CDISC standards including SDTM and ADaM.
• Strong experience in preparations for NDA filings.
• SAS Certified.
• Excellent written and verbal communication skills in English.

Details

• Location: Bangalore, Karnataka.