Centralized Statistical Monitoring, Director

Amgen•1d ago

United StatesRemoteFull-timeDirector Level8+ yrs exp

H-1B sponsor

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Career Category Clinical 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
Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases
obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture
deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative
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. Centralized Statistical Monitoring, Director What you will do Let’s do this. Let’s change the world. In this vital role you will provide strategic, statistical, technical, operational
business leadership for Centralized Statistical Monitoring (CSM). The role is accountable for the CSM analysis system, signal framework, statistical methodology, team leadership, cross-functional delivery
continued evolution of CSM as part of Amgen’s broader Risk-Based Quality Management (RBQM) and study quality oversight strategy. The successful candidate will lead CSM capability development across a growing clinical portfolio, ensuring that CSM remains scientifically rigorous, scalable, inspection-ready
aligned with portfolio, regulatory, study team
business needs. The role may also support related RBQM analytical needs, including Quality Tolerance Limit (QTL) approaches
aligned with CSM scope and portfolio priorities. Accountabilities
Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.
Lead the strategy, roadmap, operating model, and continued evolution of the CSM capability in partnership with the Head of CSM / CfDA Safety and cross-functional stakeholders.
Provide leadership and accountability for the CSM Statistics team and statistical deliverables supporting the CSM capability.
Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical study quality oversight.
Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches where aligned with CSM scope and portfolio priorities.
Lead governance, documentation, inspection readiness, lifecycle management, and long-term sustainability of the CSM capability.
Serve as a senior point of accountability for CSM-related questions, escalations, study team support, and cross-functional alignment.
Lead, coach, and develop CSM statisticians and supporting resources. Direct line management responsibilities may be in scope depending on the final operating model. Key Responsibilities
Lead the strategic development, operating model, roadmap, and continued evolution of Amgen’s Centralized Statistical Monitoring capability within the broader RBQM framework.
Serve as business owner for the CSM analysis system, partnering with Digital Technology and Statistical Programming on requirements, prioritization, SDLC activities, business validation, UAT, release readiness, lifecycle management
continuous improvement.
Provide senior statistical and technical leadership for conventional and innovative CSM methodology, including signal development, site-level analytics, anomaly detection, risk indicators, signal thresholds, QTL-related approaches where applicable
advanced statistical, machine learning
AI-enabled approaches where appropriate.
Oversee statistical review, interpretation, documentation
release of CSM signals across clinical studies, ensuring outputs are scientifically sound, traceable, inspection-ready
useful for study quality oversight.
Partner with study teams, Global Statistical Leads, Global Development Operations, Data Management, Quality, RBQM, Digital Technology
other stakeholders to support interpretation of CSM findings, issue escalation
effective use of CSM outputs.
Lead, coach, and develop CSM statisticians and supporting resources, including Amgen and Functional Service Provider resources as appropriate. Direct line management responsibilities may be in scope depending on the final operating model.
Define and maintain CSM standards, guidance, training materials, operating procedures
best practices to support consistent delivery, knowledge transfer, inspection readiness
long-term sustainability. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The person we seek is a professional with these qualifications. Basic Qualifications Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science
a related quantitative discipline and 8 years of relevant experience OR Master’s degree in Statistics, Biostatistics, Mathematics, Data Science
a related quantitative discipline and 12 years of relevant experience Preferred Qualifications
Significant statistical experience in the biopharmaceutical industry, including clinical development and clinical trial statistical oversight.
Experience with Centralized Statistical Monitoring, RBQM, QTLs, Quality by Design, data integrity, or clinical trial quality oversight.
Experience developing, evaluating, validating, or implementing statistical monitoring signals or regulated analytical deliverables in a production environment.
Experience serving as a business owner, product owner, capability lead
functional owner for an analytical, statistical
clinical system, including SDLC activities such as requirements, UAT, business validation, release readiness, documentation
lifecycle management.
Strong statistical programming and analytical skills using SAS and/or R; Python experience a plus, with experience working with clinical trial, operational, EDC, metadata, or external data sources.
Familiarity with Bayesian methods, hierarchical modeling, machine learning, advanced analytics, R Shiny, or business intelligence platforms.
People management, functional leadership, coaching, or matrix leadership experience, including leading cross-functional initiatives.
Strong communication skills, global collaboration skills, and understanding of regulatory and industry trends relevant to RBQM, clinical trial quality, data integrity, and centralized monitoring. 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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. Sponsorship Sponsorship for this role is not guaranteed. 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. . Salary Range 200,108.70USD -270,735.30 USD

Required skills

StatisticsBiostatisticsData ScienceMachine LearningAI