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Tier-1 employer and Bangalore metro increase applicant density, but role is niche and senior.
Role requires regulatory RWE and rare-disease statistical experience, limiting cross-industry transferability.
Explicit advanced statistical, regulatory, and years requirements make shortlisting rigorously selective.
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Lead statistical strategy and analytic approaches for real-world evidence generation from disease and patient registries focused on rare diseases.
Oversee design, implementation, and validation of advanced statistical models for regulatory submissions aligned with FDA, EMA, and global health authority standards.
Mentor Real World Data Statisticians and represent Alexion in regulatory interactions, advisory boards, and external collaborations.
PhD with ≥7 years or Master's with ≥10 years relevant industry experience in statistics, biostatistics, or epidemiology.
Expert proficiency in R and/or SAS; solid understanding of SQL or Python for data validation and engineering.
Experience generating real-world evidence for rare disease programs and leading registry-based regulatory submissions.
Location: Bangalore office presence expected; work from office minimum 3 days/week as per company flexibility policy.
Experienced leader in regulatory-grade real-world data statistical analyses for rare diseases with demonstrated regulatory submission impact.
Strong background in registry-specific statistical methodologies including survival analysis, causal inference, and propensity score techniques.
Track record of cross-functional collaboration and external stakeholder engagement, with strong communication skills to influence senior leadership and regulators.