Biostatistics Sr Mgr

Career Category Clinical Job Description Biostatistics Sr. Manager HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together - researching, 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. Biostatistics Sr. Manager What you will do Let’s do this. Let’s change the world. As a Biostatistics Sr. Manager, you will lead study-level statistical deliverables with substantial independence. This role manages small teams, mentors staff and ensures the delivery of high-quality statistical outputs that meet CfDA and regulatory expectations. Responsibilities: Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.​ Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)​ Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.​ Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen ’s statistical policies, procedures and strategies.​ Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product​ Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation​ Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figur