CMC Statistics Assoc Dir

Role: Associate Director of CMC Statistics at Amgen, supporting product development and manufacturing for biopharma pipeline assets across Oncology, Inflammation, and Rare Diseases. Objectives include designing statistical tools and processes to enhance compliance, consistency, and scientific innovation throughout product lifecycle stages. Responsibilities involve developing study designs, qualification and transfer of physical testing methods, statistical support for process monitoring, root-cause analysis, and continuous improvement initiatives. The role also leads the implementation of advanced statistical methodologies, supports regulatory document review, and champions the integration of AI tools for process optimization. Qualifications: Doctorate with 3+ years, Master’s with 5+ years, or Bachelor’s with 7+ years of applied statistics experience, preferably in biopharma manufacturing or control. Proficiency in statistical tools such as SAS, JMP, Design of Experiments, SPC, Process Capability Analysis, and acceptance sampling is preferred. Experience with regulatory compliance, GxP standards, and cross-functional collaboration within biotech/pharma settings is essential. The role requires excellent communication skills, and the ability to act as a scientific-technical SME. Location modality and travel specifics are not specified.