Statistical Programmer Sr

Overview

Senior Statistical Programmer supporting multiple clinical studies by developing and validating high-quality statistical programming deliverables for regulatory submissions. Works across SAS-based SDTM/ADaM workflows and supports TLGs, safety/efficacy outputs, and submission packages.

What you'll do

• Lead end-to-end programming across multiple studies and act as a client point of contact.
• Develop specifications and SAS programs for SDTM datasets and clinical data analysis deliverables.
• Develop specifications and SAS programs for ADaM datasets for trial reporting and integrated safety/efficacy analyses.
• Create, maintain, and validate Tables, Listings, and Graphs (TLGs) per biostatistical requirements and SAPs.
• Program and QC data listings, summaries, graphs, and statistical models.
• Design and maintain reusable SAS macros for Phase I–IV trial reporting and generate submission-ready outputs.

What you'll need

• Minimum 8+ years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role.
• Advanced SAS programming expertise for data extraction, integration, analysis, reporting, and automation.
• Proficiency with Base SAS, PROC SQL, SAS Macros, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS.
• Knowledge of clinical data models CDISC SDTM and ADaM.
• SAS Certified.
• Knowledge of regulatory/quality concepts including 21 CFR Part 11 and E6/E3/E9 guidelines.
• Knowledge of coding dictionaries including WHO, COSTART, ICD-9, and MedDRA.

Nice to have

• Use of R programming and converting SAS programs to R using AI tools.
• Knowledge/experience preparing NDA filings.
• Master in Statistics or related field; Master preferred.
• Experience/knowledge using AI to gain programming efficiencies.

Details

• Location: Bangalore, Karnataka.