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Tier-1 employer, Bangalore metro and mid-level title raise competition; RWE/regulatory specialization moderates applicant density.
Highly specialized RWE and regulatory statistical skills limit transferability outside biopharma and epidemiology contexts.
Explicit degree options, minimum years, SAS and regulatory RWE requirements make shortlisting highly stringent.
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Support and implement statistical analyses using real-world registry and observational data to generate evidence for regulatory submissions and scientific publications.
Contribute to the design, validation, and documentation of robust statistical methodologies tailored for registry data addressing challenges like missingness, confounding, and data linkage, ensuring compliance with global regulatory standards (FDA, EMA).
Collaborate cross-functionally with clinical, epidemiology, regulatory, and external registry teams to ensure methodological rigor, data quality, and clear communication of statistical findings aligned with regulatory strategy.
Advanced degree (PhD preferred) in statistics, biostatistics, epidemiology, or related field.
Experience: Minimum 2 years relevant industry experience with PhD or 4 years with Master’s degree in applicable field.
Proficiency in SAS for statistical programming; working knowledge of R and/or familiarity with SQL or Python is preferred.
Location requirement: Bangalore office (Manyata Tech Park) with expectation of minimum three days per week in-person work.
Experienced in applying complex statistical methods (survival analysis, causal inference, propensity scoring, longitudinal modeling) to real-world evidence from disease registries or patient populations, ideally in rare disease.
Ability to produce regulatory-grade deliverables including statistical analysis plans, briefing documents, and compliance with FDA RWE Framework and EMA registry guidance.
Comfortable collaborating with diverse stakeholders (clinical, regulatory, external investigators) to align statistical approaches with regulatory expectations and communicate complex concepts clearly.