Job
Description
Role Overview: You will be joining Amgen's Center for Design and Analysis Organization as a Safety Statistician, Senior Manager, based in Amgen India (Hyderabad). In this role, you will lead statistical activities related to the assessment of aggregate safety data for multiple studies and products. You will collaborate with cross-functional teams to provide statistical guidance for safety assessment and play a crucial role in evaluating information related to ongoing clinical trials safety assessment. Key Responsibilities: - Represent the Biostatistics function in project meetings and collaborate with cross-functional partners to provide statistical guidance for safety assessment. - Provide objective statistical expertise for the assessment and interpretation of aggregate safety data across multiple studies/products. - Develop standards for process documents, define best practices for aggregate safety statistical methodologies, and support training and guidance materials development. - Support innovative projects related to technical enhancements for safety assessment, including data visualizations and advanced analytics. - Stay updated with Amgen statistical policies, strategies, and regulatory guidance, and developments in statistical methods relevant to safety assessment. Qualifications Required: Basic Qualifications: - MSc or PhD in Statistics, Biostatistics, or related field. - Doctorate degree and 2 years of experience OR Master's degree and 4 years of experience. - Proven ability to apply statistical methods in clinical development. - Proficient in an analytical application (e.g., R or SAS). Preferred Qualifications: - Strong technical expertise with hands-on experience in statistical design and analysis. - Clinical trial experience within a pharmaceutical or medical research environment. - Experience in statistical analyses of safety data, including application of Bayesian and/or other advanced statistical methodologies. - Ability to work effectively in a globally dispersed, cross-cultural team environment. - Proficiency in developing data visualization tools and analytical applications is highly desirable. - Interest in staying current with analytical innovation relevant to safety assessment, including advanced analytics and AI-enabled approaches. Role Overview: You will be joining Amgen's Center for Design and Analysis Organization as a Safety Statistician, Senior Manager, based in Amgen India (Hyderabad). In this role, you will lead statistical activities related to the assessment of aggregate safety data for multiple studies and products. You will collaborate with cross-functional teams to provide statistical guidance for safety assessment and play a crucial role in evaluating information related to ongoing clinical trials safety assessment. Key Responsibilities: - Represent the Biostatistics function in project meetings and collaborate with cross-functional partners to provide statistical guidance for safety assessment. - Provide objective statistical expertise for the assessment and interpretation of aggregate safety data across multiple studies/products. - Develop standards for process documents, define best practices for aggregate safety statistical methodologies, and support training and guidance materials development. - Support innovative projects related to technical enhancements for safety assessment, including data visualizations and advanced analytics. - Stay updated with Amgen statistical policies, strategies, and regulatory guidance, and developments in statistical methods relevant to safety assessment. Qualifications Required: Basic Qualifications: - MSc or PhD in Statistics, Biostatistics, or related field. - Doctorate degree and 2 years of experience OR Master's degree and 4 years of experience. - Proven ability to apply statistical methods in clinical development. - Proficient in an analytical application (e.g., R or SAS). Preferred Qualifications: - Strong technical expertise with hands-on experience in statistical design and analysis. - Clinical trial experience within a pharmaceutical or medical research environment. - Experience in statistical analyses of safety data, including application of Bayesian and/or other advanced statistical methodologies. - Ability to work effectively in a globally dispersed, cross-cultural team environment. - Proficiency in developing data visualization tools and analytical applications is highly desirable. - Interest in staying current with analytical innovation relevant to safety assessment, including advanced analytics and AI-enabled approaches.
