Specialist CMC Statistician

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 anti...