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Director, Central Statistical MonitoringBeOne Medicines • New York, New York, United States
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Director, Central Statistical Monitoring

BeOne Medicines
  • US
    New York, New York, United States
  • US
    New York, New York, United States
Jetzt Bewerben

Über

Statistical Monitoring Lead BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department to support the Risk-Based Quality Management: providing statistical design, interpretation, and governance for monitoring activities that protect subject safety, ensure data integrity, and support trial reliability across BeOne's clinical development portfolios. Accountable for development, validation, and operationalization of statistical monitoring indicators and models across one or multiple studies/programs. Acts as the CSM statistician interfacing with clinical study statisticians, medical monitors, safety/pharmacovigilance, global clinical operations (GCO), quality/GCP, data management to ensure signals are interpretable, actionable, and compliance. RBQM statistical playbook; signal triage decision trees; standardized signal report templates; training materials for cross-functional stakeholders; performance dashboards tracking signal investigation metrics. In collaboration with governance bodies, defines statistical thresholds, signal characterization methods, and recommended investigative workflows. Escalates safety or major data integrity concerns to medical monitors, safety leadership, and quality with rationale. Essential Functions of the Job:
Design and validation of monitoring analytics
Develop and maintain statistical risk indicators (KRIs), anomaly detection methods, and monitoring tool appropriate for study purpose and data flows. Partner with study team to specify data derivations, edit checks, and analytic data snapshots required by CSM algorithms. Validate models and algorithms: assumptions, diagnostics, false positive/negative rates, sensitivity analyses, and reproducibility.
Signal detection, characterization, and prioritization
Implement processes to detect candidate signals across sites, subjects, and data domains (safety, efficacy, conduct, data quality). Characterize signals by magnitude, specificity, temporal dynamics, covariate dependence, and uncertainty; provide quantitative rationale for prioritization. Define and apply confidence thresholds, tiering logic (e.g., high/medium/low), and criteria for automatic alerts versus human triage.
Cross-functional interpretation and communication
Produce tiered deliverables: one-line headline for executives, concise operational briefs for GCO, and detailed technical appendices for analytic teams. Translate statistical uncertainty and model assumptions into concrete, pragmatic next actions for operations and clinical follow-up for medical monitors.
Operationalization and decision logic
Co-design decision trees, playbooks mapping signal types to investigative workflows, escalation paths, and CAPA triggers. Ensure feedback loops: incorporate investigation outcomes (true/false/insufficient) to recalibrate models and to improve data collection or derivation rules. Participate in RBQM governance meetings to align statistical approaches with study risk tolerances and regulatory expectations.
Training, governance, and stakeholder enablement
Develop and deliver training modules for clinical monitors, safety officers, DM staff, and study teams on interpreting CSM outputs and on required actions. Provide statistical support during audits/inspections and contribute to CAPA design when monitoring uncovers systemic issues. Act as a change agent: promote a risk-based mindset, help define governance criteria, and support SOP updates.
Performance monitoring and continuous improvement
Define KPIs for CSM effectiveness: time-to-investigation, confirmation rate, and downstream corrective actions. Monitor performance dashboards, conduct periodic reviews, and implement improvements to models, thresholds, and communication templates.
Supervisory Responsibilities:
Yes
Required background:
Master's degree with 7 years' experience or Ph.D with 5 years' experience in biostatistics/statistics or related quantitative field. Demonstrated experience in clinical trial statistics RBQM/CSM, and signal triage. Strong stakeholder management and communication skills Experience with model lifecycle management, validation, and documentation for audits/inspections
Computer Skills: Microsoft Office, PowerBI Other Qualifications: N/A Travel: Occasionally travelling is expected Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity
Salary Range: $187,100.00 - $247,100.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
  • New York, New York, United States

Sprachkenntnisse

  • English
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