Career Category
Research
Job Description
Safety Statistician, Senior Manager
What you will do
Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. Amgen’s Center for Design and Analysis Organization has a current opportunity for a Safety Statistician, Senior Manager, to provide independent statistical 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 and 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.
Responsibilities:
- Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide sound statistical guidance for safety assessment.
- Act as an independent statistician,
providing objective statistical expertise for the assessment and interpretation of aggregate safety data across multiple studies/products and formulating sound conclusions and recommendations.
- Provide safety statistics expertise on aggregated safety analysis plans (ASAP) and safety assessment and reporting activities across multiple studies/products.
- Develop, maintain, and set standards for associated controlled process documents, including defining best practices for aggregate safety statistical methodologies, and support the development and application of related training and guidance materials across programs.
- Support innovative projects related to technical enhancements for safety assessment, involving data visualizations, decision-making toolkits, and appropriate advanced analytics, including AI integration.
- Maintain familiarity with Amgen statistical policies, strategies, and regulatory gui