Director CMC Statistics - Cambridge MA

Director CMC Statistics - Cambridge MA

Director, CMC Modeling & Advanced Statistics

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

In this vital role, you will serve as Amgen's leader in advanced statistical modeling for CMC development and commercial support. Reporting to the Senior Director, CMC Statistics, you will drive innovation in kinetic modeling, Bayesian statistics, and predictive methods to accelerate decision-making across Amgen's product portfolio. You will also ensure best-in-class application of advanced modeling techniques to CMC data, spanning drug substance, drug product, and delivery device development.

As Director, CMC Modeling & Advanced Statistics, you will:

• Provide strategic and technical leadership in the design and implementation of kinetic modeling, Bayesian methods, and predictive analytics to support product and process characterization, stability modeling, and specification setting.
• Lead development and application of statistical/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 are aligned 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 & guide other statisticians & data scientists in the use of innovative statistical approaches, including but not limited to kinetic, Bayesian, and predictive modeling.

Basic Qualifications:

• Doctorate degree and 4 years of relevant biopharmaceutical industry experience OR Master's degree and 8 years of relevant biopharmaceutical industry experience OR Bachelor's degree and 10 years of relevant biopharmaceutical industry experience
• In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Preferred Qualifications:

• Degree in Statistics, Biostatistics, Applied Mathematics, Engineering, or related quantitative field.
• Deep expertise in kinetic modeling, Bayesian methods, and advanced statistical modeling techniques.
• 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 ability to explain complex modeling approaches to both technical and non-technical audiences.
• Experience working in cross-functional and global team environments.

What you can expect of us:

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

Salary Range $207,002.00 - $238,637.00

City: Cambridge

State: Massachusetts

Job Code: Pharmaceutical

Company: Amgen