Senior/Principal Statistical Programmer

Overview

Applies statistics and data analysis to advance clinical study design, including sample size calculations and quantitative assessments, within Clinical Sciences.

What you'll do

• Conduct sample size calculations and quantitative assessments to support clinical study designs.
• Collaborate with peers across functions to influence technical decisions and promote data-driven analytics.
• Produce formal technical reports and presentations summarizing analyses for technical leaders and management.
• Create and present technical documentation and analyses that inform local and network-level decisions.
• Develop CDISC-compliant (ADaM/SDTM) submission-ready datasets, ensuring data integrity and regulatory alignment.
• Design and execute statistical analysis plans to support clinical development and regulatory submissions.
• Track and ensure compliance with evolving regulatory requirements affecting statistical analysis and data submissions.
• Validate and ensure accuracy and consistency of statistical programming code and outputs for clinical submissions.

Nice to have

• Familiarity with scripting or basic automation to support data workflows.
• Exposure to industry standards and analytical approaches guiding experiments.
• Awareness of validation concepts applicable to computerized systems and data integrity.

Details

• Location: Bengaluru, India.