Associate Director I/II, Real World Data Statistics
AstraZeneca (company site, opens in a new tab)10+ yrsBengaluruOn-siteDirect career pageEst. 35–55 LPA
Posted 17d ago
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Job description
Structured overview of role & requirements
About This Role
- Lead design and implementation of advanced statistical analyses using registry and real-world data for regulatory submissions in rare diseases.
- Oversee development of regulatory-quality deliverables aligned with FDA, EMA, and global guidelines ensuring reproducibility and audit readiness.
- Provide leadership across functions and mentor Real World Data Statisticians to build technical expertise and ensure regulatory compliance.
Minimum Requirements
- PhD with minimum 7 years relevant industry experience or Master’s degree with minimum 10 years relevant industry experience in statistics, biostatistics, epidemiology or related field.
- Expert proficiency with R and/or SAS; understanding of SQL or Python for data engineering and validation.
- Experience in generating real-world evidence for rare disease programs and leading regulatory submissions.
- Location: Must work on-site at Manyata Tech Park, Bangalore (minimum 3 days per week).
Ideal Candidate Profile
- Experienced in applying advanced statistical methodologies to registry-based real-world data for regulatory-grade evidence generation.
- Proven ability to influence and communicate complex statistical analyses to senior leadership and regulatory authorities globally.
- Demonstrated leadership in collaborative, cross-functional settings with external stakeholders including registry investigators and regulatory consultants.