27 Aug
|
Alexion Pharmaceuticals
|
Bengaluru
27 Aug
Alexion Pharmaceuticals
Bengaluru
Location: Bengaluru, India Job reference: R-257200 Date posted: 07/27/2026
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 cutting-edge 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 reproduc
📌 Associate Director I/ii, Real World Data Statistics (Bengaluru)
🏢 Alexion Pharmaceuticals
📍 Bengaluru