Principal Cmc Statistician

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.

**Principal 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 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 provide multi-functional support to clinical and commercial manufacturing sites in the network including statistical support for activities such as process characterization and monitoring programs, analytical methods, specifications, and investigations.

The statistician may also support 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 aligned with Amgen and Regulatory/ISO requirements.
- 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 and/or R code, outlining report templates, and aligning relevant SOPs.
- 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.
- 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 guides statistical techniques and software tools to technical associates.
- Stays up to date on biotechnology industry trends, standard processes, 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 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 8 to 10 years of applied statistics experience **OR**,
- Bachelor’s Degree in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 10 to 14 years of applied statistics experience **OR**,
- Diploma in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 14 to 18 years of applied statistics experience

**Preferred Qualifications**:

- Post-graduate degree with 6+ 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 and/or R programming (data manipulation techniques, macro, statistical and graphical PROCs, and ODS) and JMP statistical software

**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.
- Vast opportunities to learn and move up and across our global organizati