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
Regulatory-grade real-world evidence generation
Survival and longitudinal modeling
Collaboration with clinical and regulatory teams
Compliance with FDA and EMA guidelines
Use of R and/or SAS for analytics
Nice-to-have
Proficiency in SQL or Python
Experience with rare disease programs
Strong communication and influence skills
Peer-reviewed publications or presentations
Methodological innovation in registry data
Key Requirements
Advanced degree or equivalent in statistics or epidemiology
Experience with regulatory submissions for FDA and EMA
Proven track record in real-world evidence for rare diseases
Ability to support regulatory advisory meetings
Compliance with FDA RWE Framework and EMA registry guidance