Biostatistics Senior Manager, Biosimilars

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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Biostatistics Senior Manager, Biosimilars

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What you will do

Let’s do this. Let’s change the world. In this vital role, you will independently lead a single large product and/or more complex studies and/or projects, ensure that all statistical aspects of documentation of clinical activities meet required standards and are statistically correct, influence and contribute to the development strategy, and defend statistics.

Responsibilities:

• Implements, oversees, and supports standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis.

• Plans and implements 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 or 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 areas as well as cross-functionally.

• Is familiar with statistical policy and strategy at Amgen; has a working knowledge of theoretical and applied statistics, regulatory guidelines, and industry practice on biosimilar development.

• Stays abreast of the latest developments in the field of statistics in drug development and contributes to scientific advances by publishing applied research in scientific journals and books and communicating statistical methodology at internal or external scientific meetings.

• Participates in the review of CRO policies, SOPs, and other controlled document development, and in the …