Bangalore, भारत
Vacancy description
Associate Director I/II, Real World Data Statistics in Bangalore, भारत
AstraZeneca
Bangalore, भारत
AstraZeneca seeks an Associate Director in Real World Data Statistics to lead statistical strategies for registry-based evidence supporting rare disease therapies. This individual contributor role involves designing regulatory-grade analyses, driving methodological innovation, and mentoring team members while collaborating across clinical, regulatory, and external stakeholders.
Responsibilities
- Lead design and implementation of advanced statistical analyses from disease registries and real-world data sources for regulatory submissions
- Drive cross-functional collaboration with registry, clinical, regulatory, and epidemiology teams on submissions to FDA, EMA, and other health authorities
- Oversee development of regulatory-quality deliverables including statistical analysis plans, tables, figures, and regulatory briefing documents
- Mentor and support professional development of other Real World Data Statisticians within the epidemiology team
- Define and implement robust statistical approaches addressing registry-specific challenges such as missingness, confounding, and outcome validation
Requirements
- PhD with 7+ years relevant industry experience, or Master's with 10+ years
- Advanced degree in statistics, biostatistics, or epidemiology
- Expert proficiency with R and/or SAS; solid SQL or Python knowledge
- Track record generating real-world evidence for rare disease programs
- Experience leading regulatory submissions with registry-based analyses
- Expertise in data quality, cohort construction, linkage, and missing data strategies
- Demonstrated leadership through peer-reviewed publications or conference presentations
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