CMC Statistics Assoc Dir
Amgen
August 29, 2026
Remote friendly (United States)
United States
Operations
What You Will Do
- Implement statistical tools and techniques to support product manufacturing and testing across the product life cycle.
- Provide statistical support to clinical and commercial manufacturing sites (monitoring programs, analytical methods, investigations, and root-cause analysis for protocol/method deviations).
- Support development of delivery devices; develop study designs; create acceptance sampling plans and acceptance criteria for physical test methods development/qualification/transfer.
- Evaluate acceptance criteria for design verification testing for compliance with Amgen and Regulatory/ISO requirements.
- Support component/material qualifications using process capability analysis and equivalence tests.
- Lead continuous improvement/harmonization, drive efficiency and scientific innovation, and administer statistical training.
Key Responsibilities (skills-driven)
- Drive improvements/standardization in statistical analysis.
- Use AI tools to enhance business processes.
- Review/quality oversight of technical documents; support SOP/controlled document development.
- Maintain statistical tools (white papers, standardized SAS code, report templates).
- Lead cross-functional teams; serve as business/scientific-technical SME; stay current on trends; participate in conferences.
What We Expect Of You
Basic Qualifications
- Doctorate + 3 years OR Master’s + 5 years OR Bachelor’s + 7 years OR Associate’s + 12 years OR High school/GED + 14 years in Applied/Industrial Statistics or Non-clinical Biostatistics.
Preferred Qualifications
- Advanced degree; 5 years applying statistics to biopharma manufacturing/control.
- Expertise in: Design of Experiments, Statistical Process Control, Process Capability, Measurement System Analysis, Acceptance Sampling, regression, significance tests, simulation.
- Proficient in SAS (data manipulation, macros, statistical/graphical PROCs, ODS) and JMP.
- Excellent communication.
Benefits (high level, if eligible)
- Health/welfare, retirement/savings, bonus/incentives, stock-based long-term incentives, time-off, flexible work models.
Application
- Apply now via careers.amgen.com.
- Implement statistical tools and techniques to support product manufacturing and testing across the product life cycle.
- Provide statistical support to clinical and commercial manufacturing sites (monitoring programs, analytical methods, investigations, and root-cause analysis for protocol/method deviations).
- Support development of delivery devices; develop study designs; create acceptance sampling plans and acceptance criteria for physical test methods development/qualification/transfer.
- Evaluate acceptance criteria for design verification testing for compliance with Amgen and Regulatory/ISO requirements.
- Support component/material qualifications using process capability analysis and equivalence tests.
- Lead continuous improvement/harmonization, drive efficiency and scientific innovation, and administer statistical training.
Key Responsibilities (skills-driven)
- Drive improvements/standardization in statistical analysis.
- Use AI tools to enhance business processes.
- Review/quality oversight of technical documents; support SOP/controlled document development.
- Maintain statistical tools (white papers, standardized SAS code, report templates).
- Lead cross-functional teams; serve as business/scientific-technical SME; stay current on trends; participate in conferences.
What We Expect Of You
Basic Qualifications
- Doctorate + 3 years OR Master’s + 5 years OR Bachelor’s + 7 years OR Associate’s + 12 years OR High school/GED + 14 years in Applied/Industrial Statistics or Non-clinical Biostatistics.
Preferred Qualifications
- Advanced degree; 5 years applying statistics to biopharma manufacturing/control.
- Expertise in: Design of Experiments, Statistical Process Control, Process Capability, Measurement System Analysis, Acceptance Sampling, regression, significance tests, simulation.
- Proficient in SAS (data manipulation, macros, statistical/graphical PROCs, ODS) and JMP.
- Excellent communication.
Benefits (high level, if eligible)
- Health/welfare, retirement/savings, bonus/incentives, stock-based long-term incentives, time-off, flexible work models.
Application
- Apply now via careers.amgen.com.