Amgen Inc. is hiring a Director CMC Statistics

Amgen Inc. is looking for a Director, CMC Statistics to serve as the company's leader in advanced statistical modeling for Chemistry, Manufacturing, and Controls (CMC) development and commercial support. This role drives innovation in kinetic modeling, Bayesian statistics, and predictive methods to accelerate decision-making across Amgen's product portfolio.

What You'll Do

• Provide strategic and technical leadership in designing and implementing kinetic modeling, Bayesian methods, and predictive analytics to support product and process characterization, stability modeling, and specification setting.
• Lead the development and application of statistical and mathematical models to optimize manufacturing processes, evaluate product lifecycle and stability data, and support regulatory submissions.
• Champion the integration of Bayesian methods and modeling frameworks to enhance data utilization, manage uncertainty, and improve decision-making across the CMC lifecycle.
• Partner with cross-functional teams (Process Development, Analytical Sciences, Quality, Manufacturing, and Regulatory) to ensure modeling strategies align with Amgen's business and scientific objectives.
• Contribute to regulatory strategies by developing and defending modeling-based justifications in submissions and at regulatory authority interactions.
• Advance Amgen's digital and data science strategy by incorporating machine learning, simulation, AI, and automation approaches into statistical workflows.
• Represent Amgen externally through scientific collaborations, publications, and conference presentations to establish thought leadership in CMC modeling.
• Train and guide other statisticians and data scientists in the use of innovative statistical approaches, including kinetic, Bayesian, and predictive modeling.

What We're Looking For

• A Doctorate degree and 4 years of relevant biopharmaceutical industry experience OR a Master's degree and 8 years of relevant experience OR a Bachelor's degree and 10 years of relevant experience.
• At least 4 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Nice to Have

• A degree in Statistics, Biostatistics, Applied Mathematics, Engineering, or a related quantitative field.
• Deep expertise in kinetic modeling, Bayesian methods, and advanced statistical modeling techniques.
• A strong track record of applying statistical modeling to CMC data, including stability, comparability, process characterization, and analytical method development.
• Proficiency with statistical software (e.g., R, SAS, JMP, Minitab) and modeling tools (e.g., NONMEM, MATLAB, Stan, or similar Bayesian frameworks).
• Demonstrated success influencing regulatory strategies through modeling-based approaches.
• Proven ability to lead and develop technical talent in statistics and modeling.
• Excellent oral and written communication skills, with the ability to explain complex modeling approaches to both technical and non-technical audiences.
• Experience working in cross-functional and global team environments.

Technical Stack

• R, SAS, JMP, Minitab
• NONMEM, MATLAB, Stan

Team & Environment

Reporting to the Senior Director, CMC Statistics.

Benefits & Compensation

• Compensation range: $207,002.00 USD - $238,637.00 USD.
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

Work Mode

This is a hybrid position. The role is open to candidates across the U.S., excluding Puerto Rico.

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.