Senior Manager-Safety Biostatistics

Job Description

As a Safety Statistician, Senior Manager at Amgen, you will play a crucial role in providing independent statistical expertise to Safety Assessment Teams and biostatistical colleagues for safety data analysis. Your responsibilities will include representing the Biostatistics function in project team meetings, collaborating with cross-functional partners, and providing statistical guidance for safety assessment. You will lead statistical activities related to aggregate safety data for multiple studies and products, formulating conclusions and recommendations based on sound statistical judgment.Key Responsibilities:- Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide statistical guidance for safety assessment.- Act as an independent statistician, providing statistical expertise for the interpretation of aggregate safety data across multiple studies/products and formulating sound conclusions.- Provide safety statistics expertise on aggregated safety analysis plans and reporting activities across multiple studies/products.- Develop and maintain standards for associated controlled process documents, defining best practices for aggregate safety statistical methodologies.- Support innovative projects related to technical enhancements for safety assessment, including data visualizations and advanced analytics integration.- Stay updated with Amgen statistical policies, strategies, and regulatory guidance relevant to safety assessment.Qualifications Required:Basic Qualifications:- MSc or PhD in Statistics, Biostatistics, or related field.- Doctorate degree with 2 years of experience OR Masters degree with 4 years of experience.- Proven ability to apply statistical methods in clinical development.- Proficiency in analytical applications such as R or SAS.Preferred Qualifications:- Strong technical expertise in statistical design and analysis.- Clinical trial experience in a pharmaceutical or medical research setting.- Experience in statistical analyses of safety data using advanced methodologies.- Ability to work effectively in a globally dispersed, cross-cultural team environment.- Proficiency in developing data visualization tools and analytical applications like R/Shiny.- Interest in staying current with analytical innovation relevant to safety assessment, including AI-enabled approaches.Please note that this position is currently located at Amgen India (Hyderabad).As an employee at Amgen, you can expect a Total Rewards Plan that includes comprehensive health and welfare plans, financial benefits, work/life balance, and career development opportunities. The benefits package comprises retirement and savings plans, medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, annual bonus programs, stock-based long-term incentives, time-off plans, and flexible work models including remote work arrangements. As a Safety Statistician, Senior Manager at Amgen, you will play a crucial role in providing independent statistical expertise to Safety Assessment Teams and biostatistical colleagues for safety data analysis. Your responsibilities will include representing the Biostatistics function in project team meetings, collaborating with cross-functional partners, and providing statistical guidance for safety assessment. You will lead statistical activities related to aggregate safety data for multiple studies and products, formulating conclusions and recommendations based on sound statistical judgment.Key Responsibilities:- Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide statistical guidance for safety assessment.- Act as an independent statistician, providing statistical expertise for the interpretation of aggregate safety data across multiple studies/products and formulating sound conclusions.- Provide safety statistics expertise on aggregated safety analysis plans and reporting activities across multiple studies/products.- Develop and maintain standards for associated controlled process documents, defining best practices for aggregate safety statistical methodologies.- Support innovative projects related to technical enhancements for safety assessment, including data visualizations and advanced analytics integration.- Stay updated with Amgen statistical policies, strategies, and regulatory guidance relevant to safety assessment.Qualifications Required:Basic Qualifications:- MSc or PhD in Statistics, Biostatistics, or related field.- Doctorate degree with 2 years of experience OR Masters degree with 4 years of experience.- Proven ability to apply statistical methods in clinical development.- Proficiency in analytical applications such as R or SAS.Preferred Qualifications:- Strong technical expertise in statistical design and analysis.- Clinical trial experience in a

Keyskills :
Bayesian statisticsData visualizationAdvanced analyticsStatistical expertiseClinical trial experienceAnalytical applications