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Senior, niche RWE role at a Tier-1 pharma in Bangalore increases applicant interest but limits broad competition.
Highly specialized regulatory RWE and rare-disease biostatistics skills reduce cross-industry transferability.
Explicit advanced-degree plus 7–10+ years regulatory RWE experience and mandatory tool proficiency increases shortlisting rigor.
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Lead the statistical strategy and analytical oversight for registry-based evidence generating regulatory submissions in rare disease programs.
Design, implement, and validate complex statistical models (survival analysis, causal inference, propensity scores, longitudinal models) tailored for real-world registry data meeting FDA, EMA, and other global regulators' standards.
Mentor and guide Real World Data Statisticians while ensuring methodological rigor, reproducibility, and adherence to AstraZeneca standards in statistical deliverables for regulatory approval processes.
PhD with minimum 7 years of relevant industry experience OR Master's degree with minimum 10 years of relevant industry experience in statistics, biostatistics, or epidemiology.
Expert proficiency in R and/or SAS; solid working knowledge of SQL or Python for data engineering and validation.
Demonstrated experience generating real-world evidence from registry or observational data aligned to regulatory submissions (FDA, EMA).
Location Requirement: Based in Bangalore (Manyata Tech Park) with expectation of minimum 3 days/week in office.
Experienced in leading regulatory-grade statistical analyses and submissions using disease registry and real-world data for rare diseases, with familiarity of FDA and EMA regulatory frameworks.
Strong operational leader able to collaborate cross-functionally and externally, influencing senior leaders and regulatory authorities with compelling evidence narratives.
Proven track record in mentoring statisticians, implementing innovative statistical methods dealing with registry-specific challenges such as data linkage, missing data, confounding, and outcome validation.