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Tier-1 brand, mid-level experience band, and Bangalore metro location increase candidate competition significantly.
High — regulatory RWE/statistics and registry-specific expertise limit cross-industry transferability.
Requires advanced degree, specific years of industry RWE/statistics experience, and regulatory/tool proficiency, so filters are strict.
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Lead the design and delivery of advanced statistical analyses and regulatory-grade evidence from disease and patient registries to support global regulatory submissions and label expansions.
Develop and validate registry-specific statistical methodologies addressing challenges like missing data, data linkage, confounding, and outcome validation aligned with FDA and EMA frameworks.
Collaborate cross-functionally and externally with clinical, epidemiology, regulatory, and registry teams to ensure methodological rigor, data quality, and produce audit-ready, reproducible statistical reports and briefing documents.
PhD degree with minimum 4 years relevant industry experience or Master's degree with minimum 6 years relevant industry experience in statistics, biostatistics, or epidemiology.
Hands-on proficiency in R and/or SAS; understanding of SQL or Python for data engineering and validation.
Experience generating real-world evidence and contributing to regulatory submissions using registry-based analyses for rare disease programs.
Location requirement: Must be able to work from Manyata Tech Park, Bangalore minimum 3 days per week (hybrid work model).
Proven ability in applying sophisticated statistical models (survival analysis, causal inference, propensity score matching, longitudinal models) to registry and longitudinal real-world data in regulated environments.
Experience collaborating with multi-disciplinary teams and external investigators to maintain high methodological and regulatory standards.
Demonstrated experience presenting and influencing within regulatory and advisory meetings, with a track record of regulatory-compliant deliverables for global health authorities (FDA, EMA).