Job Description

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.

PRINCIPAL 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 Principal CMC Statistician will use their expertise to implement statistical tools and techniques with science-based practices used throughout the product life cycle. The statistician will support the Final Product Technology team in the development of delivery devices, where they 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 and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is compliant with Amgen and Regulatory/ISO requirements. They will support component and material qualifications using process capability analysis and equivalence tests. Ad-hoc statistical support will be provided for root-cause analysis for protocol or method deviations.

The statistician will also provide support to clinical and commercial manufacturing sites in the network. This involves statistical support for monitoring programs, analytical methods and investigations. 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 Principal CMC Statistician include:

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.
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 Amgen’s document control system and has statistical integrity.
Supports regulatory audits by interacting with technical staff to answer questions during on- site inspections; and, provides written responses to clarify a statistical approach or perform additional analysis to support a Request for Information, 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 highly motivated professional we seek is a passionate individual with these qualifications.

Basic Qualifications

Doctorate degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 2 years of applied statistics experience Or

Master’s degree in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 6 years of applied statistics experience Or

Bachelor’s degree in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 8 years of applied statistics experience Or

Associate’s degree and 10 years of applied statistics experience Or

High school diploma / GED and 12 years of applied statistics experience

Preferred Qualifications:

Doctorate degree with 5 years’ experience in 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.
Proficient in SAS programming (data manipulation techniques, macro, statistical and graphical PROCs, and ODS) and JMP statistical software

THRIVE

WHAT YOU CAN EXPECT OF US

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.

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