Director, Biostatistician (Evergreen)

Embedded Shishya; Deutschland; Vor Ort; EUR 161.865 - 213.773; Vollzeit

Benefits dieser Stelle

Comprehensive benefits package

Annual bonus plan

Employee Stock Purchase Plan

Zusammenfassung

Dormont Manufacturing Co is looking for an experienced professional to lead the Central Statistical Monitoring team in Germany. This role involves developing statistical monitoring indicators and working collaboratively across various departments to ensure data integrity and compliance.

The ideal candidate will have a Master’s or Ph.D. in a quantitative field, supported by several years in clinical trial statistics and strong stakeholder management skills. The position offers a comprehensive benefits package and a competitive salary range.

Qualifikationen

• Master’s degree with 7 years’ experience or Ph.D with 5 years’ experience in biostatistics/statistics.
• Demonstrated experience in clinical trial statistics.
• Experience with model lifecycle management and validation for audits.

Aufgaben

• Lead the Central Statistical Monitoring team to support risk-based quality management.
• Develop and maintain statistical risk indicators and monitoring analytics.
• Produce tiered deliverables and translate uncertainties into actions.

Kenntnisse

Statistical monitoring

Stakeholder management

Data analysis

Communication skills

Ausbildung

Master’s degree in biostatistics/statistics or related quantitative field

Tools

Microsoft Office

PowerBI

Jobbeschreibung

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.

General Description

Lead the Central Statistical Monitoring (CSM) team within the Global Statistics department to support the RBQM: 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

• 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 [e-mail].