Safety Statistician, Senior Manager
Career Category
ClinicalJob 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. Join us.
Safety Statistician, Senior Manager
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What you will do
Let’s do this. Let’s change the world. Amgen’s Center for Design and Analysis Organization has a new opportunity for a Safety Statistician, Senior Manager to provide expertise to our Safety Assessment Teams and biostatistical colleagues in safety data analysis. In this vital role, you will lead the statistical activities related to the assessment of aggregate safety data for multiple studies/products. You will be part of a cross-functional team, which will provide clinical and statistical judgment to evaluate the totality of the information related to ongoing clinical trials safety assessment. As a Safety Statistician, Senior Manager, your key activities will include:
- 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 in safety assessment.
- Authors and provides statistical leadership on aggregated safety analysis plans (ASAP) and safety assessment and reporting activities across multiple studies/products.
- Support of projects related to technical enhancements to support safety assessment, including data visualizations and decision-making toolkits.
- Performs aggregate safety statistical analyses of multiple studies/projects and subsequent exploratory analyses and makes sound conclusions and recommendations.
- 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