Director Statistics

1 week ago

New Delhi, India Domnic Lewis Full time

We are hiring for a global leader in Pharma for "Director- Real World Statistics " .Exp- 18-25 yrsLocation- BangaloreAccountabilities:Design and implement advanced statistical analyses for regulatory submissions using data from disease registries, patient registries, natural history studies, EMR, and claims data.• Collaborate with registry teams and support in regulatory interactions, ensuring registry-derived analyses align with regulatory strategy.• Prepare regulatory-quality results including statistical reports and clinical study reports based on registry analyses.• Develop and validate statistical methodologies for real-world evidence generation from registry sources.• Mentor junior statisticians and data scientists in regulatory-compliant registry data analysis techniques.Essential Skills/Experience:Doctoral degree in Biostatistics, Statistics, Epidemiology, Mathematics, Data Science, or related field with at least6 years in the pharmaceutical industry, biotechnology, or consulting environment; or Master’s degree in Computer Science, Statistics, Mathematics, Data Science, or related field.At least 10 years industry experience in the pharmaceutical industry, biotechnology, or consulting environment.Desirable Skills/Experience:Hands-on technical expertise with proficiency in statistical programming languages (R, SAS, SQL) and regulatory-compliant programming standards.• Proven track record of successful regulatory submissions incorporating registry data. Extensive experience with regulatory applications of disease registries and natural history studies.• Deep familiarity with regulatory standards and guidelines including ICH guidelines, FDA Real-World Evidence Framework, EMA guidance on registry-based studies.• Strong background in regulatory statistics with specific expertise in registry-based regulatory submissions.• Demonstrated ability to build long-term relationships with regulatory agencies and lead multi-disciplinary regulatory-focused statistical projects.

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