Senior Statistical Programmer / Data Scientist

Avenga is seeking a rigorous and detail-oriented Statistical Programmer or Data Scientist dedicated to the statistical validation of Digital Health Technologies. In this role, you will focus on authoring comprehensive Statistical Analysis Plans and executing regulatory-grade programming for analytical and clinical validation within the V3 framework to support digital solutions for Parkinson's and Huntington's disease.

Key responsibilities

• Co-author rigorous Statistical Analysis Plans to demonstrate that digital health technologies reliably measure physiological metrics compared to gold-standard reference devices.
• Select, justify, and document appropriate statistical methods and success criteria to meet FDA and EMA evidence expectations.
• Write clean, modular, and highly documented code in Python to execute analysis plans and generate regulatory-compliant datasets, tables, and figures.
• Implement rigorous software development best practices, including version control, automated unit testing, and peer code reviews.
• Maintain comprehensive documentation detailing data lineage and programming specifications to ensure all evidence is audit-ready.

Requirements

• At least 4 years of industry experience in a pharmaceutical, medical device, or CRO environment focused on clinical trial statistics and programming.
• Direct experience preparing statistical evidence for regulatory bodies like the FDA or EMA.
• Deep expertise in statistical methods for method comparison, agreement, and reliability.
• Expert-level proficiency in statistical programming using Python.
• Strong working knowledge of CDISC standards and regulatory frameworks for digital health technologies.

What we offer

• Opportunity to work on innovative digital biomarkers for clinical trials.
• Fully remote work environment with a focus on high-quality, reproducible research.
• Collaboration with cross-functional teams including clinical, regulatory, and engineering experts.