Biostatistics Manager
Job title: Biostatistics Manager in USA at Amgen
Company: Amgen
Job description: Career Category ClinicalJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Biostatistics ManagerLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Biostatistics Manager independently leads sophisticated studies in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary study teams.WinWhat we expect of youWe are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is proficient with these qualifications.Key activities include:
Expected salary: $139595 - 170664 per year
Location: USA
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Company: Amgen
Job description: Career Category ClinicalJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Biostatistics ManagerLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of, CfDA (Center for Design & Analysis). The Biostatistics Manager independently leads sophisticated studies in the General Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and valid. Will also influence and supply to strategy development, defend statistical approaches and represent GBS (Global Biostatical Science) through participating in and collaborating with multidisciplinary study teams.WinWhat we expect of youWe are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is proficient with these qualifications.Key activities include:
- Providing statistical contributions, statistical review, and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
- Completing statistical analysis of individual studies/projects
- Publishing applied research in scientific journals and books, and giving presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
- Being familiar with statistical policy and strategy at Amgen
- Staying abreast of the latest developments in the field of statistics in drug development and contributing to scientific advances in the field
- Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
- Assisting in the review of Amgen Policies, SOPs, and other controlled documents
- Assisting with study and systems audits conducted by Amgen CQA and external bodies
- Serving as team member of change / process improvement initiatives
- Doctorate degree
- Master’s degree and 2 years of Statistics/Biostatistics experience
- Bachelor’s degree and 4 years of Statistics/Biostatistics experience.
- Associate’s degree and 8 years of Statistics/Biostatistics experience.
- High school diploma / GED and 10 years of Statistics/Biostatistics experience.
- Doctorate degree in statistics or biostatistics
- A 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
- Flexible work models, including remote and hybrid work arrangements, where possible
Expected salary: $139595 - 170664 per year
Location: USA
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