Senior Manager, Centralized Statistical Monitoring

🕒 vor 2 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $154.104 - $208.494 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

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Amgen

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1980

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

💰 €28.500.000.000 Post-IPO Debt im 2022-12

Biotechnology • Pharmaceuticals • Science

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 CSM • 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 • Support governance, documentation, inspection readiness, and long-term sustainability of the CSM capability • Lead statistical review, interpretation, documentation, and release of CSM signals across clinical studies • 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 • Lead, coach, and develop statisticians and colleagues supporting CSM activities

🎯 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 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 • 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.

🏖️ Vorteile

• 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 • 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.