Amgen is seeking a Senior Quality Engineer (Non Clinical CMS Statistician) to be part of the Global Quality Engineering (GQE) team. We are pursuing highly motivated, mid-level career candidates, who are passionate practitioners of non-clinical statistics. The successful candidate will contribute to Amgen’s pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives.
As part of the Global Quality Engineering team, the Senior 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 Senior Statistician includes:
• 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 onsite 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.
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 3 years of applied statistics experience Bachelor’s degree and 5 years of experience in applied statistics OR Associate’s degree and 10 years of experience in applied statistics OR High school diploma / GED and 12 years of experience in applied statistics
• 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.
• Proven experience delivering on projects and demonstrated use of effectively using statistical and problem- solving skills.
• Strong communication skills, written and verbal, and experience with client engagement: candidates will have outstanding experience engaging directly with clients (scientific/biological experience is preferred) to use statistical approaches in a science-based culture.
• Ability to work well under time constraints and to prioritize workload.
• Familiarity and background with biotechnology manufacturing processes and regulatory requirements, e.g., Chemistry, Manufacturing, and Controls (CMC) for the biologics and monoclonal antibodies.
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
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.