You will craft regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfill post-market commitments
Job Summary
You will craft regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfill post-market commitments.
Joining our growing epidemiology and real-world evidence capability, you will apply statistical methodologies tailored for registries, align to AstraZeneca standards, and contribute to a portfolio that demands rigor, creativity, and impact.
We balance the expectation of being in the office while respecting individual flexibility, working a minimum of three days per week from the office.
Matching Summary
You will craft regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfill post-market commitments.
Skills & Requirements
Must-have
Statistical analyses of disease registries
Real-world evidence generation
Regulatory-grade survival and longitudinal models
Collaboration with clinical and regulatory teams
Compliance with FDA and EMA guidance
Proficiency in R and/or SAS
Registry-specific statistical methodologies
Nice-to-have
Experience with rare disease programs
Strong communication and influence skills
Knowledge of SQL or Python for data validation
Peer-reviewed publications or conference presentations
Innovative methodological development
Flexible in-office work arrangement
Key Requirements
Advanced degree or equivalent in statistics or epidemiology
Experience with regulatory submissions for FDA and EMA