Director CMC Statistics
Director CMC Statistics
United States - Remote APLICAR AHORAJoin Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Director, CMC Modeling & Advanced Statistics
What you will do
Let’s do this. Let’s change the world. 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
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. Your managerial experience may run concurrently with the required technical experience referenced above
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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.