Biostatistics Senior Manager, Biosimilars US- Remote

About the Role Amgen is seeking a Biostatistics Senior Manager for Biosimilars to lead statistical strategy for a major product and/or complex studies. The role ensures all statistical aspects of clinical documentation meet required standards, informs development strategy, and defends statistical approaches internally and externally. This position supports CRO partnerships in a full-service model and works across functions in a remote US setting.

What You'll Do

• Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Plans and executes statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model.
• 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 CROs in a full-service CRO model.
• 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 aspects.

What We're Looking For

• Experience leading statistical contributions for large products and/or complex studies; ability to influence development strategy.
• Expertise in protocols, SAPs, TLGs, SDFs, CSRs, CSSs, CSEs, COs, and regulatory documentation.
• Demonstrated ability to oversee CROs and work within a full-service CRO model.
• Strong collaboration, communication, and scientific defendability of statistical approaches.