Principal CMC Statistician

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 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.

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

• 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 Amgens 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,
• Masters Degree in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 8 to 10 years of applied statistics experience OR,
• Bachelors 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