Senior Director, CMC Statistics

Career Category

Job Description

Join 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.

Senior Director, CMC Statistics

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide strategic input to technical and business initiatives and supervise key aspects of CMC statistics support for Amgen’s pipeline and commercial products across different therapeutic areas.

The Senior Director, CMC Statistics, will manage, act as a technical expert for, and provide quality oversight of the Global CMC Statistics (GCS) Team. The mission of the GCS team is to design, develop and promote standard methodologies, processes and tools across Operations that drive consistency and enhance compliance. Statisticians within GCS use their expertise to implement and automate statistical tools and techniques to support product manufacturing and testing throughout the product life cycle. The GCS team identifies and promotes innovations in statistical applications via external engagement and internal development. The team also provides support to clinical and commercial manufacturing sites in the Operations network including activities such as product specifications and stability, product and process characterization and monitoring programs, analytical methods, investigations, and other ad-hoc analyses.

The GCS team also supports the development of delivery devices and systems, and provides statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification, and transfer of physical test methods. They also establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is aligned with Amgen and Regulatory/ISO requirements, and support component and material qualifications using process capability analysis and equivalence tests.

Finally, the Senior Director, CMC Statistics will contribute to continuous improvement efforts across Amgen’s networks, leading to harmonization, efficiency gains, scientific innovation and administration of statistical training for engineers and scientists.

• Identify and champion innovation and transformation in Amgen’s management of CMC data, using evolving capabilities in data science, automation, machine learning/AI, predictive statistics, and other enablers.

• Collaborate with cross functional partners across Operations, including statisticians and data scientists at the Amgen India Capability Center, to advance Amgen’s technology strategies

• Lead and ensure statistical excellence in the design, analysis and reporting for all phases of CMC development across multiple functional and organizational areas including investigations, strategic statistical process control programs, Gage R&R studies, design of experiments, and Operations development plans.

• Development and implementation of statistical strategy for CMC development programs ensuring standards, technical quality and consistent approaches in CMC development strategy, study design and statistical analysis while maintaining organizational standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.

• Reviews and provide Quality oversight as needed of product and study level documents such as regulatory documents, study protocols, statistical analysis plans, technical reports, and sample plans

• Support the development and review of Policies, SOPs and other controlled documents within Amgen or CROs for process improvement and operational efficiency.

• Provide statistical leadership for regulatory strategies, presentations and scientific reports for CMC development, regulatory submissions, response to questions, and scientific presentations and publications.

• Provides coaching, mento