Senior Manager, Centralized Statistical Monitoring

🕒 Junho 5

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $154.104 - $208.493 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Provide statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM) • Serve as business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows • Lead the CSM Statistics team and oversee statistical deliverables supporting the CSM capability • Partner with the Head of CSM / CfDA Safety to shape and execute CSM strategy, roadmap, and operating model • Advance CSM methodology within the Risk-Based Quality Management framework • Prioritize system enhancements, signal development, automation opportunities, and related RBQM analytical needs • Support governance, documentation, inspection readiness, and long-term sustainability • Serve as senior contact for CSM questions, escalations, and study team support • Define and maintain CSM standards, guidance, operating procedures, and best practices • Lead business-related Software Development Life Cycle activities, including requirements definition, prioritization, user acceptance testing, business validation, release readiness, and lifecycle management • Partner with Digital Technology and statistical programming colleagues on system strategy, implementation, testing, documentation, and continuous improvement • Provide statistical expertise on site-level analytics, outlier detection, trend analysis, anomaly detection, risk indicators, signal thresholds, comparative analytics, and QTL approaches • Develop and enhance CSM signals for evolving study designs, endpoint types, data sources, and portfolio needs • Lead statistical review, interpretation, documentation, and release of CSM signals across clinical studies • Support study teams with signal interpretation, statistical rationale, and follow-up actions • Support the CSM inquiry and triage model for questions, escalations, and signal interpretation requests • Lead, coach, and develop statisticians and colleagues supporting CSM activities • Build partnerships across Statistics, Digital Technology, Programming, Data Management, Clinical Operations, Quality, RBQM, Global Statistical Leads, and other stakeholders

🎯 Requisitos

• Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 4 years of relevant experience, OR Master’s degree in one of these fields and 8 years of relevant experience, OR Bachelor’s degree in one of these fields and 10 years of relevant experience • 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 • Sponsorship for this role is not guaranteed

🏖️ Benefícios

• Health and welfare plans for staff and eligible dependents • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Reasonable accommodation for individuals with disabilities