Director CMC Statistics Cambridge MA
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Job Location:
Cambridge, MA - USA
Monthly Salary:
$ 238637 - 238637
Posted on:
11-11-2025
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans 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 click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Lets do this. Lets change the this vital role you will serve as Amgens 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 Amgens 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 Amgens business and scientific objectives.
Contribute to regulatory strategies by developing and defending modeling-based justifications in submissions and at regulatory authority interactions.
Advance Amgens 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
Lets do this. Lets change the this vital role you will serve as Amgens 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 Amgens 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 Amgens business and scientific objectives.
Contribute to regulatory strategies by developing and defending modeling-based justifications in submissions and at regulatory authority interactions.
Advance Amgens 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
Additional Qualifications/Responsibilities
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
Masters degree and 8 years of relevant biopharmaceutical industry experience OR
Bachelors 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 well support your journey every step of the way.
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Salary Range
207002.00 USD - 238637.00 USD
Required Experience:
Director
Key Skills
- Fundraising
- Management Experience
- Coaching
- Analysis Skills
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Mentoring
- Public Speaking
- negotiation
- Supervising Experience
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
