Associate Director, Real World Data Statistics
ROLE OVERVIEW
Alexion, AstraZeneca's rare disease unit, is expanding its epidemiology and real-world evidence capability in Bangalore with an Associate Director I/II, Real World Data Statistics. This individual-contributor leadership role sits at the intersection of advanced biostatistics and regulatory science, converting disease registry, natural history, EMR and claims data into evidence robust enough to withstand FDA, EMA and other health authority scrutiny. The position matters because rare disease programmes depend on external data to characterise small, dispersed patient populations, support label expansions and satisfy post-market commitments. For an experienced statistician it offers unusual scope: methodological innovation in missingness, linkage and confounding control, direct exposure to health authority interactions, and mentorship of a growing RWD statistics function within a biotech-paced, patient-centred environment backed by AstraZeneca's global scale.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead statistical strategy and analysis plans for registry-based evidence supporting rare disease regulatory submissions and post-market commitments.
- •Design, program and validate survival analyses, causal inference, propensity score matching and longitudinal models on registry, EMR and claims data.
- •Develop regulatory-quality deliverables — statistical analysis plans, tables/figures/listings and briefing documents — aligned to the FDA RWE Framework and EMA registry guidance.
- •Innovate methodologies for missingness, data linkage, confounding control and outcome validation, sharing findings internally and through publications.
- •Partner with clinical, epidemiology, regulatory and registry operations teams, and represent Alexion at advisory boards and health authority meetings.
- •Ensure reproducibility, audit readiness and transparent reporting across all statistical deliverables.
- •Translate complex analyses into clear narratives for executive leadership and submission dossiers.
- •Mentor RWD statisticians through code review, knowledge-sharing and career development guidance.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- PhD in statistics, biostatistics or epidemiology with a minimum of 7 years of relevant industry experience.
- Or a Master's degree with a minimum of 10 years of relevant pharmaceutical, CRO or observational research experience.
- Proven track record of generating real-world evidence for rare disease or similarly small patient populations.
- Demonstrated leadership of regulatory submissions built on registry-based analyses.
- Experience presenting analyses in health authority or scientific advisory settings.
- Expert proficiency in R and/or SAS, with working knowledge of SQL or Python for data engineering and validation.
- Strong publication or conference record in pharmacoepidemiology or applied RWE methodology.
PREFERRED QUALIFICATIONS
- •Rare disease and orphan drug regulatory experience
- •Health authority briefing document authorship
- •CDISC and regulatory submission data standards
- •Statistical capability building and mentorship
- •Pharmacoepidemiology publication leadership
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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