Job Description

Career Category QualityJoin Amgenxe2x80x99s Mission of Serving PatientsAt Amgen, if you feel like youxe2x80x99re part of something bigger, itxe2x80x99s because you are. Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do.Since 1980, wexe2x80x99ve helped pioneer the world of biotech in our fight against the worldxe2x80x99s toughest diseases. With our focus on four therapeutic areas xe2x80x93Oncology, Inflammation, General Medicine, and Rare Diseasexe2x80x93 we reach millions of patients each year. As a member of the Amgen team, youxe2x80x99ll 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, youxe2x80x99ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Principal CMC StatisticianWhat you will doLetxe2x80x99s do this. Letxe2x80x99s change the world. In this vital role you will contribute to Amgenxe2x80x99s 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 Amgenxe2x80x99s networks, leading to harmonization, efficiency gains and scientific innovation and, administration of statistical training for Amgenxe2x80x99s 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 Amgenxe2x80x99s 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 youWe 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,Masterxe2x80x99s Degree in Applied Statistics, Industrial Statistics or Non-Clinical Biostatistics and 8 to 10 years of applied statistics experience OR,Bachelorxe2x80x99s 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 experiencePreferred Qualifications:Post-graduate degree with 6+ yearsxe2x80x99 experience in Biopharma manufacturing and controlProficient 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 softwareWhat you can expect of usAs 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsIn addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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..

Amgen