Senior Manager, Centralized Statistical Monitoring

🕒 vor 4 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $154.104 - $208.493 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

👻 Geisterscore 45%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Amgen

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1980

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

💰 €28.500.000.000 Post-IPO Debt im 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen ist ein weltweit führendes Unternehmen in der Biotechnologie, das sich auf die Entwicklung und Vermarktung innovativer Arzneimittel aus lebenden Zellen konzentriert. Das Unternehmen hat zum Ziel, schwere Krankheiten zu behandeln, wobei oft Krankheiten im Fokus stehen, für die es nur begrenzte therapeutische Möglichkeiten gibt. Amgen legt großen Wert auf wissenschaftliche Innovation und ist der ethischen Forschung, der Patientensicherheit und der ökologischen Nachhaltigkeit verpflichtet. Es ist aktiv in klinischen Studien engagiert und bekannt für seine Beiträge in den Bereichen Krebsbehandlung und Adipositas-Management unter anderem.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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