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At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Biostatistics Senior Manager
Job Responsibility
Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs
Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis
Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Providing input for clinical publications and regulatory filing documents
Leading all aspects of work performed by study statisticians
Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations
Anticipating and communicating resource and quality challenges that could impact results or timelines
Solid understanding of regulatory guidelines in drug development
Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen's statistical policies, procedures and strategies
Contributing to process improvements and operational efficiencies
Requirements
Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of Biostatistics experience
Master's degree in Statistics/Biostatistics or related subject with high statistical content and at least 4 years of Biostatistics experience
Bachelor's degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of Biostatistics experience
Associate's degree and 10 years of experience
High school diploma / GED and 12 years of experience
Nice to have
Doctorate degree in biostatics or statistics
5 or more years of pharma/biotech statistical experience
Life cycle drug development experience (pre-clinical, clinical and post-marketing)
Experience with cardiovascular drug development
Proven in leadership and motivating multi-functional team to advance complex projects to completion and thoughtfully negotiate and influence
Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
Statistical leadership and contribution to regulatory and reimbursement submissions
Strong working knowledge of theoretical and applied statistics and of regulatory guidelines
Experience working effectively in a globally dispersed team environment with cross-cultural partners
What we offer
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