Biostatistics Sr. Mgr
The Senior Manager of Biostatistics independently leads a single product, and/or more complex studies and/or projects, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy, and defends statistical approaches internally and externally.
- Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
- Plans and executes statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
- Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
- Oversees statistical work performed by study statisticians.
- Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses, and makes sound conclusions and recommendations.
- Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams (e.g. provides support and input in case report form design, and data collection).
- Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
- Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines.
- Stays abreast of latest developments in the field of statistics in drug development (innovative trial design), Contributes to process improvement and operational efficiency.
- Adheres to all Amgen Policies, Standard operation procedures (SOPs).
- Doctorate degree and 2 years of Biostatistics experience
- Master's degree and 6 years of Biostatistics experience
- Bachelor's degree and 8 years of Biostatistics experience
- Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
- Statistical leadership and contribution to regulatory or reimbursement submissions
- Experience working effectively in a globally dispersed team environment with cross-cultural partners