Senior Manager, Centralized Statistical Monitoring

🕒 June 5

🇺🇸 United States – Remote

💵 $154.1k - $208.5k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 45%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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