Principal CMC Statistician-US Remote

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal CMC Statistician-US Remote

Live

What you will do

Lets do this. Lets change the world. In this vital role you will contribute to Amgens pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives.

The Principal CMC Statistician will be a member of our Global CMC Statistics (GCS) team. The mission of the GCS team is to design, develop and promote best practices, processes and tools across Operations that drive consistency and enhance compliance. As part of the Global CMC Statistics team, the Principal CMC Statistician will use their expertise to implement statistical tools and techniques that support product manufacturing and testing throughout the product life cycle. The statistician will also provide support to clinical and commercial manufacturing sites in the Operations network. This involves statistical support for monitoring programs, analytical methods, investigations, and other ad-hoc analyses.

The Principal CMC statistician will support the development of delivery devices and systems, and will 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, carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is compliant with Amgen and Regulatory/ISO requirements, and support component and material qualifications using process capability analysis and equivalence tests.

Finally, the candidate will contribute to continuous improvement efforts across Amgens networks, leading to harmonization, efficiency gains and scientific innovation, and will administer statistical training for Amgens engineers and scientists.

Primary Responsibilities for the Principal CMC Statistician include:

• Provides continuous statistical support to a site or functional group by consulting with technical associates to develop an experimental study, perform statistical analysis, and document results in a technical report that complies with Amgens document control system and has statistical integrity.
• Acts as a technical lead in the development, implementation and maintenance of statistical tools used to support product life cycle activities. This may include, drafting/updating white papers, writing standardized SAS code, outlining report templates, and aligning relevant SOPs.
• Supports regulatory audits by interacting with technical staff to answer questions during on- site inspections; and provides written responses to clarify or justify a statistical approach, or perform additional analysis to support regulatory submissions, as required.
• Participates in improvement efforts to promote statistical techniques used in biologics and monoclonal antibodies processes; and mentors and teaches 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 dedicated professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree in Applied Statistics, Industrial Statistics, or Non-clinical Biostatistics and 3 years of experience in a related field or

Masters degree in Applied Statistics, Industrial Statistics, or Non-clinical Biostatistics and 5 years of experience or

Bachelor's degree in Applied Statistics, Industrial Statistics, or Non-clinical Biostatistics and at least 5 years of experience or

Associate's degree and at least 10 years of experience

Preferred Qualifications:

Advanced degree with 5 years experience applying statistical methodologies to Biopharma manufacturing and control

Proficient in statistical tools and techniques commonly used in biopharma manufacturing 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.

Thrive

• 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

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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Thrive

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization
• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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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.