Manager Biostatistics (Study Statistician and/or Study Lead Statistician)
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Biostatistics Manager to lead statistical strategy and execution for clinical studies within its India operations. The role involves managing statistical deliverables, ensuring regulatory compliance, and collaborating across functional teams to support clinical trial operations.
What they're looking for
- MSc or PhD in Statistics, Biostatistics, or related discipline
- 5+ years industry experience (Study Statistician) or 8+ years (Study Lead Statistician)
- Demonstrated ability to apply statistical methods in clinical development
- Knowledge of CfDA and regulatory standards for drug development
- Experience with statistical analysis plans, protocols, and clinical documentation
- Machine learning, real-world data analytics, or clinical trial simulation experience (preferred)
What you'll be doing
- Review and provide quality control of study design documents, protocols, and key design elements
- Lead statistical contributions to randomization specifications, analysis plans, and submission documentation
- Develop tables, figures, listings, and clinical study reports with cross-functional collaboration
- Serve as Global Biostatistics lead on Clinical Study Team, ensuring protocol adherence and data quality
- Maintain statistics sections of trial master files and communicate findings to internal and external stakeholders
Privacy & handoff
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