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Director Statistics

Director Statistics

Domnic LewisBengaluru, Karnataka, India
8 hours ago
Job description

We are hiring for a global leader in Pharma for " Director- Real World Statistics " .

Exp- 18-25 yrs

Location- Bangalore

Accountabilities :

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 least

6 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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    Director • Bengaluru, Karnataka, India