26 Aug
|
AstraZeneca
|
Bengaluru
26 Aug
AstraZeneca
Bengaluru
Location Bengaluru, Karnataka, India Job ID R-257200 Date posted 26/07/2026
Job Title:Associate Director I/II, Real World Data Statistics
Global Career Level: E
Role: Individual contributor role
Location: Manyata Tech Park, Bangalore.
About Alexion
At Alexion, our mission is to transform the lives of people affected by rare diseases through the development and delivery of creative medicines as well as supportive technologies and healthcare services.
Introduction to role:
Do you thrive at the intersection of statistics, real-world evidence, and regulatory science? Step into a role where your expertise in disease registries and longitudinal observational cohorts directly advances therapies for patients. You will lead the development of regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfill post-market commitments.
Accountabilities:
Registry Evidence Strategy: Oversee the statistical vision and analytical strategies for registry-based evidence,
crafting regulatory submissions and decisions across rare disease programs.
Regulatory-Grade Analyses: Oversee the design, implementation, and validation of survival, causal inference, propensity score, and longitudinal models tailored for registry data; produce analyses that meet global regulatory expectations.
Methodological Innovation: Define, program, and implement robust, registry-specific statistical approaches addressing challenges such as missingness, data linkage, confounding, and outcome validation; elevate practice through shared findings.
Cross-Functional and External Collaboration: Provide leadership to clinical, epidemiology, regulatory, and registry operations teams; represent Alexion in external forums, advisory boards, and regulatory discussions.
Standards, Quality, and Compliance: Lead and ensure alignment with AstraZeneca standard methodologies and guidance (e.g., FDA RWE Framework, EMA registry guidance); ensure reprodu
📌 Associate Director I/ii, Real World Data Statistics (Bengaluru)
🏢 AstraZeneca
📍 Bengaluru