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Strong employer brand plus metro location, but very specialized role reduces generic applicant density.
Role requires niche rare-disease RWE and regulatory statistics expertise, limiting cross-industry transferability.
Explicit senior years, advanced degree preference, and regulatory RWE methodological mandates create strict shortlisting.
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Lead statistical strategies and regulatory-grade analyses using real-world data from disease registries to support rare disease program submissions.
Oversee design, validation, and implementation of advanced statistical models (e.g., survival, causal inference, longitudinal) meeting FDA and EMA regulatory standards.
Mentor and lead Real World Data Statisticians, collaborate cross-functionally and represent the company in external regulatory and advisory forums.
PhD with minimum 7 years or Master's degree with minimum 10 years in statistics, biostatistics, or epidemiology or equivalent industry experience.
Expert proficiency in R and/or SAS; solid understanding of SQL or Python for data engineering/validation.
Experience leading regulatory submissions and producing regulatory-compliant deliverables with real-world evidence from registries.
Work Location: Bangalore (Manyata Tech Park); In-person work required minimum 3 days per week.
Proven track record of generating regulatory-grade real-world evidence for rare disease or patient registries, including health authority interactions.
Experience leading methodological innovation and maintaining alignment with global regulatory guidelines and standards (FDA RWE Framework, EMA registry guidance).
Demonstrated leadership in mentoring statisticians and presenting complex statistical concepts clearly to senior leadership and regulatory bodies.