Amgen
Safety Statistician, Senior Manager
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, 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. 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; having working knowledge of theoretical and applied statistics and of regulatory guidelines. Stays abreast of latest developments in the field of statistics in drug development, notably in the field of safety assessment and reporting. Adheres to all Amgen Policies, Standard operation procedures (SOPs). We are all different, yet we all use our unique contributions to serve patients. The statistical professional we seek is a strong with these qualifications. Doctorate degree and 2 years of statistical clinical trial experience Master's degree and 4 years of statistical clinical trial experience OR Bachelor's degree and 6 years of statistical clinical trial experience OR Associate's degree and 10 years of statistical clinical trial experience OR High school diploma / GED and 12 years of statistical clinical trial experience Technically strong with hands on experience of various design and statistical analysis Clinical trial experience Any safety assessment experience and/or experience of application of Bayesian methodology in clinical trials environment is a plus Experience working effectively in a globally dispersed team environment with cross-cultural partners Proficiency in developing or supervising the development of data visualization tools and data analysis applications using eg. R/Shiny is highly desirable As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Join us.
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, 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. 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; having working knowledge of theoretical and applied statistics and of regulatory guidelines. Stays abreast of latest developments in the field of statistics in drug development, notably in the field of safety assessment and reporting. Adheres to all Amgen Policies, Standard operation procedures (SOPs). We are all different, yet we all use our unique contributions to serve patients. The statistical professional we seek is a strong with these qualifications. Doctorate degree and 2 years of statistical clinical trial experience Master's degree and 4 years of statistical clinical trial experience OR Bachelor's degree and 6 years of statistical clinical trial experience OR Associate's degree and 10 years of statistical clinical trial experience OR High school diploma / GED and 12 years of statistical clinical trial experience Technically strong with hands on experience of various design and statistical analysis Clinical trial experience Any safety assessment experience and/or experience of application of Bayesian methodology in clinical trials environment is a plus Experience working effectively in a globally dispersed team environment with cross-cultural partners Proficiency in developing or supervising the development of data visualization tools and data analysis applications using eg. R/Shiny is highly desirable As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Join us.