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Tier-1 pharma brand and Bangalore location increase applicant density despite niche registry RWE specialization.
Requires regulatory, rare-disease registry and RWE expertise, limiting cross-industry transferability.
Explicit advanced degree, 4–6 years industry experience and regulatory RWE requirements increase selectivity.
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Define and deliver analytical strategies for registry-based real-world evidence to support regulatory submissions for rare disease programs.
Lead the design, implementation, and validation of statistical models tailored to registry data ensuring compliance with global regulatory standards (FDA, EMA).
Collaborate cross-functionally and externally to maintain methodological rigor, drive reproducibility, and produce regulatory-quality deliverables influencing health authority decisions.
PhD 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 with R and/or SAS; solid understanding of SQL or Python for data engineering and validation.
Experience generating regulatory-grade real-world evidence from disease registries or longitudinal observational cohorts.
Location requirement: Based in Bangalore (Manyata Tech Park) with minimum three days per week onsite work.
Experienced in applying advanced statistical methodologies (survival analysis, causal inference, propensity scoring, longitudinal models) in regulatory submissions for rare diseases.
Proven ability to translate complex statistical results into clear narratives for regulatory and advisory settings, influencing collaborations and health authorities.
Demonstrated history of methodological innovation and adherence to regulatory frameworks like FDA RWE and EMA registry guidance, with peer-reviewed publications or relevant presentations.