VetJobs
Amgen is seeking a Director, CMC Modeling & Advanced Statistics to lead advanced statistical modeling for CMC development and commercial support. The role is on‑site in Cambridge, MA and reports to the Senior Director, CMC Statistics.
Responsibilities
Provide strategic and technical leadership in 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 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, Regulatory) to align modeling strategies with 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 into statistical workflows.
Represent Amgen externally through scientific collaborations, publications, and conference presentations to establish thought leadership in CMC modeling.
Train and guide statisticians and data scientists in innovative statistical approaches, including kinetic, Bayesian, and predictive modeling.
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.
At least 4 years of experience directly managing people and/or leading teams, projects, or programs.
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 applying statistical modeling to CMC data (stability, comparability, process characterization, analytical method development).
Proficiency with statistical software (R, SAS, JMP, Minitab) and modeling tools (NONMEM, MATLAB, Stan, or similar).
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 to technical and non‑technical audiences.
Experience working in cross‑functional and global team environments.
Benefits & Compensation
Salary Range: 207,002.00 USD – 238,637.00 USD.
Location: Cambridge, MA.
AutoReq ID: 458810BR
Minimum Education Required: High School/GED
#J-18808-Ljbffr
Responsibilities
Provide strategic and technical leadership in 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 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, Regulatory) to align modeling strategies with 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 into statistical workflows.
Represent Amgen externally through scientific collaborations, publications, and conference presentations to establish thought leadership in CMC modeling.
Train and guide statisticians and data scientists in innovative statistical approaches, including kinetic, Bayesian, and predictive modeling.
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.
At least 4 years of experience directly managing people and/or leading teams, projects, or programs.
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 applying statistical modeling to CMC data (stability, comparability, process characterization, analytical method development).
Proficiency with statistical software (R, SAS, JMP, Minitab) and modeling tools (NONMEM, MATLAB, Stan, or similar).
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 to technical and non‑technical audiences.
Experience working in cross‑functional and global team environments.
Benefits & Compensation
Salary Range: 207,002.00 USD – 238,637.00 USD.
Location: Cambridge, MA.
AutoReq ID: 458810BR
Minimum Education Required: High School/GED
#J-18808-Ljbffr