SafetyStatistician,Manager

## **Career Category** Research ## ## **Job Description** **Safety Statistician, 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 new opportunity for a **Safety Statistician, Manager** to provide statistical expertise in support of safety assessment activities across clinical development programs. In this role, you will contribute to the assessment and interpretation of aggregate safety data across multiple studies and products, working closely with Safety Assessment Teams and cross-functional partners. You will apply sound statistical judgment to support safety evaluation and reporting throughout the clinical trial lifecycle. **Responsibilities:** * Provide statistical expertise to support the assessment and interpretation of aggregate safety data across multiple studies and programs. * Contribute to the development and execution of aggregated safety analysis plans and related safety assessment and reporting activities. * Perform statistical analyses of safety data, including exploratory analyses, and contribute to the interpretation of results and formulation of conclusions. * Collaborate with cross-functional partners to provide statistical input into safety assessment discussions and deliverables. * Support the development and application of statistical methods, tools, and analyses for safety assessment, including data visualizations and advanced analytical approaches where appropriate. * Apply knowledge of statistical principles, regulatory guidance, and internal standards to ensure quality and consistency of safety analyses. * Stay current with developments in statistical methodology and analytical innovation relevant to safety assessment. * Adhere to all Amgen policies and Standard Operating Procedures (SOPs). This position is currently located at Amgen India (Hyderabad).