Specialist CMC Statistician

Job Description

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 Bachelors degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 5 years of experience or Associates 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