Centralized Statistical Monitoring, Senior Manager
Remote · Not stated
Hiring locations: United States - Remote
Open posting at AmgenCheck the posting for country and time zone requirements before applying.
Employer’s description
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, and 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, and 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, 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. Centralized Statistical Monitoring - Senior Manager What you will do Let’s do this. Let’s change the world. In this vital role you will provide statistical, technical, operational, and business leadership for CSM, helping ensure that study quality oversight is scientifically rigorous, scalable, inspection-ready, and aligned with the needs of a growing clinical portfolio. The role may also support related Risk-Based Quality Management (RBQM) analytical needs, including Quality Tolerance Limit (QTL) approaches, where aligned with the CSM capability and portfolio priorities. Accountabilities • Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows. • Provide leadership for the CSM Statistics team and accountability for statistical deliverables supporting the CSM capability. • Partner with the Head of CSM / CfDA Safety to shape and execute the strategy, roadmap, and operating model for CSM. • Advance CSM methodology within the broader RBQM framework to support Quality by Design, data quality, data integrity, and 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. • Support governance, documentation, inspection readiness, and long-term sustainability of the CSM capability. • Serve as a senior point of contact for CSM-related questions, escalations, and study team support. Key Responsibilities Strategic and Operational Leadership • Support the continued development of CSM within the broader RBQM framework. Translate portfolio needs, study team feedback, regulatory expectations, and technical considerations into clear business, statistical, and operational requirements. • Define and maintain CSM standards, guidance, operating procedures, and best practices to support consistent delivery across studies. CSM System Ownership • Lead business-related aspects of the Software Development Life Cycle for the CSM system, including requirements definition, prioritization, user acceptance testing, business validation, release readiness, and lifecycle management. • Partner with Digital Technology and statistical programming colleagues to support system strategy, production implementation, testing, documentation, and continuous improvement. Methodology and Innovation • Provide statistical expertise on CSM methodology, including site-level analytics, outlier detection, trend analysis, anomaly detection, risk indicators, signal thresholds, comparative analytics, and QTL approaches where applicable. • Lead or support the development of new and enhanced CSM signals in response to evolving study designs, endpoint types, data sources, and portfolio needs. Evaluate innovative approaches, including advanced modeling, small-sample methods, Bayesian approaches, adaptive thresholds, machine learning, and AI-enabled analytics where appropriate. Study Support and Signal Delivery • Lead statistical review, interpretation, documentation, and release of CSM signals across clinical studies, ensuring quality and traceability. • Support study teams in understanding signal outputs, statistical rationale, and appropriate follow-up actions. Provide statistical judgment on unusual signal patterns, data quality concerns, operational risks, and potential study-level or site-level issues. • Support the CSM inquiry and triage model for study team questions, escalations, and signal interpretation requests, ensuring requests are routed and addressed appropriately. Team Leadership and Cross-Functional Partnership • Lead, coach, and develop statisticians and colleagues supporting CSM activities, including Amgen and Functional Service Provider resources as appropriate. • Build strong partnerships across Statistics, Digital Technology, Programming, Data Management, Clinical Operations, Quality, RBQM, Global Statistical Leads, and other cross-functional stakeholders. 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, or a related quantitative discipline and 4 years of relevant experience, OR • Master’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience, OR • Bachelor’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 10 years of relevant experience Preferred Qualifications • Statistical experience in the biopharmaceutical industry including clinical development. • Experience with CSM, RBQM, QTLs, Quality by Design, 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 or functional owner for an analytical system, including business-related aspects of the Software Development Life Cycle. • Strong statistical programming and analytical skills using SAS and/or R. • Familiarity with Bayesian methods, hierarchical modeling, machine learning, or advanced analytics. • Experience with interactive visualization tools such as R Shiny and/or business intelligence platforms. • People management, functional leadership, coaching, or matrix leadership experience, including leading cross-functional initiatives. • Experience developing SOPs, standards, guidance, or operating procedures. • Strong communication skills and ability to work effectively in a globally dispersed, cross-cultural environment. • Understanding of regulatory and industry trends relevant to RBQM, clinical trial quality, 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 154,104.15USD -208,493.85 USD