Specialist CMC Statistician

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

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. 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.

Specialist CMC Statistician

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 R and 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

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 and/or R programming (data manipulation techniques, macro, statistical and graphical PROCS, and ODS) and JMP statistical software

Excellent interpersonal, oral and written communication skills

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.

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