Senior Director, CMC Statistics
Senior 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.
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, mentoring, and supports development of GCS staff
Recruits and retains professionals for the GCS organization
Stay abreast of and contribute to scientific and innovative advances in the field and ensuring internal practices are current.
Represent the statistical function at meetings with regulatory authorities, key opinion leaders and other specialist bodies and defending statistical approaches
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The biostatistical professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
Doctorate degree and 5 years of statistical experience in the biopharmaceutical industry experience
Or
Master’s degree and 9 years of statistical experience in the biopharmaceutical industry experience
Or
Bachelor’s degree and 11 years of statistical experience in the biopharmaceutical industry experience
In addition to meeting at least one of the above requirements, you must have at least 5 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 or other subject with high statistical content
Knowledgeable of statistical methodology and applications within drug development
Demonstrated effective oral, presentation and written communication skills
Ability to use word processing, briefing and spreadsheet software and statistical analysis software such as JMP and minitab, and SAS programming (data manipulation techniques, macro, statistical and graphical PROCs, and ODS)
Statistical leadership for regulatory submissions
Ten years post-graduate statistical experience in the biopharmaceutical industry and mastery of statistical approaches and methodology used to support pharmaceutical CMC development and lifecycle management including such activities as specifications, comparability, stability, statistical process control, process characterization, delivery device design and verification, and analytical method development
Demonstrated ability to drive innovation by implementing new methodologies and relevant statistical designs
Demonstrated leadership attributes with a consistent track record in charting the course and developing high-performance teams
Background in working within a global team and with CRO partners to ensure operational excellence and efficiencies
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 $227,702 00 to $262,501.00. 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.