Department: Not specified
Location: Not specified
At Amgen, our mission is to serve patients living with serious illnesses. Since 1980, we've been pioneering biotech to fight the world's toughest diseases, with a focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Our work reaches millions of patients each year, helping them live fuller, longer, and healthier lives. We pride ourselves on our award-winning, collaborative, and science-based culture that fosters innovation and excellence.
The Principal CMC Statistician plays a critical role in Amgen’s pipeline, supporting the development, qualification, and transfer of physical test methods for new molecules and commercial products. You will contribute to the lifecycle of products by providing statistical analysis, study designs, and acceptance criteria, ensuring that all activities align with Amgen’s goals and regulatory requirements. Additionally, you will promote continuous improvement and help administer statistical training for engineers and scientists.
Statistical Support & Analysis:
Provide statistical analysis for activities such as process characterization, monitoring programs, analytical methods, specifications, and investigations across clinical and commercial manufacturing sites.
Study Design & Acceptance Criteria:
Establish study designs, perform evaluations, and assess acceptance criteria for Design Verification testing, aligning with Amgen’s and regulatory requirements.
Statistical Tools & Techniques:
Act as a technical lead for developing, implementing, and maintaining statistical tools and techniques for product lifecycle activities, including SAS and/or R code development and writing standardized report templates.
Collaborative Support:
Collaborate with technical teams to develop experimental studies, perform statistical analysis, and document results in accordance with Amgen’s document control system.
Regulatory Support:
Support regulatory audits and inspections, providing statistical responses to queries and additional analyses as needed.
Continuous Improvement:
Promote statistical techniques in biologics and monoclonal antibody processes and mentor technical associates on statistical software tools.
Industry Engagement:
Stay up to date on industry trends and guidance documents, participating in external conferences to share knowledge.
Career Growth:
Amgen offers vast opportunities for learning and career progression within a global organization.
Inclusive Environment:
A diverse community where every team member is empowered to contribute ideas and lead initiatives.
Competitive Benefits:
Amgen provides a comprehensive Total Rewards Plan, including health, finance, work-life balance, and career benefits.
Amgen is an Equal Opportunity Employer, considering all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other characteristic protected by applicable law. Reasonable accommodations are available for applicants with disabilities throughout the hiring process.
To apply, visit careers.amgen.com
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Kyiv |Lima Region :
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