Job Description

**HOW 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. **Specialist CMC Statistician** **Live** **What you will do** Let’s do this. Let’s change the world. In this vital role you will contribute to Amgen’s pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives. The Specialist CMC Statistician will be a member of our Global CMC Statistics (GCS) team. The mission of the team is to design, develop, and promote best practices, processes and tools across Operations that drive consistency and improve compliance. As part of the GCS team, the Specialist CMC Statistician will work with members of the team to implement statistical tools and techniques to support product manufacturing and testing throughout the product life cycle. The statistician will provide support to clinical and commercial manufacturing sites in the network. This involves statistical support for analyzing Operations generated data including monitoring programs, analytical methods, investigations, and other ad-hoc analyses as required. The Specialist CMC statistician will also support development of delivery devices and systems, and provide statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification, and transfer of physical test methods. They will also establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is aligned with Amgen and Regulatory/ISO requirements. Finally, the candidate will contribute to continuous improvement efforts across Amgen’s networks, leading to harmonization, efficiency gains and scientific innovation and, administration of statistical training for Amgen’s engineers and scientists. Primary Responsibilities for the Specialist CMC Statistician include: + Provides continuous statistical support to a site or functional group by collaborating with technical associates to develop an experimental study, perform statistical analysis, and document results in a technical report that aligns with Amgen’s document control system and has statistical integrity. + Provides written responses to clarify and/or explain a statistical approach and performs additional analysis to support regulatory submissions and response to questions, as required. + Participates in the development, implementation and maintenance of statistical tools used to support product life cycle activities assisting with drafting/updating white papers, writing standardized SAS code, outlining report templates, and aligning GCS duties in relevant SOPs. + Participates in improvement efforts to promote statistical techniques used in biologics and monoclonal antibodies processes; and mentors and guides statistical techniques and software tools to technical associates. + Stays up to date on biotechnology industry trends, best practices, guidance documents and participates in external conferences, as appropriate **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The highly motivated professional we seek is a collaborate partner with these qualifications. **Basic Qualifications:** Doctorate degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics or Master’s degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 3 years of experience or Bachelor's degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 5 years of experience or Associate's degree and 10 years of experience **Preferred Qualifications:** Advanced degree in Applied or Industrial Statistics with 3 years’ experience applying statistical methodologies to support Biopharma manufacturing and control Proficient in statistical tools and techniques commonly used in biopharma manufacturing and testing operations, such as Design of Experiments, Statistical Process Control, Process Capability Analysis, Measurement System Analysis, Acceptance Sampling Plans, Non-linear and Linear Regression, Significance Tests, and Simulation. Proficient in SAS programming (data manipulation techniques, macro, statistical and graphical PROCS, and ODS) and JMP statistical software Excellent interpersonal, oral and written communication skills **Thrive** **Some of the vast rewards of working here** As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. + Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey + A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act + Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor **Apply now** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** \#LI-Remote Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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