Principal Biostatistician - ML/AI & RWE Dashboards

Edwards Lifesciences; Irvine (CA); Vor Ort; USD 132.000 - 186.000; Vollzeit

Benefits dieser Stelle

Benefits programs

Zusammenfassung

Edwards Lifesciences is seeking a Principal Biostatistician to drive machine learning and AI-driven analytics for clinical and real-world evidence projects. You will develop Python-based dashboards, apply causal inference methods, and guide analyses for Phase 4 studies and registries to support cross-functional teams.

You will mentor junior statisticians, contribute to SOPs and WIMs, and collaborate with stakeholders on regulatory submissions while ensuring data integrity and regulatory

Qualifikationen

• PhD or equivalent in Statistics/Biostatistics or related field.
• 2 years’ experience in a statistical role within clinical trials or related field.

Aufgaben

• Lead statistical analyses for multiple clinical trials and support study reports.
• Provide statistical expertise for NPD and regulatory submissions (PMAs, CE marks, PMDA).
• Coordinate project status updates with management and teams.
• Develop data-driven solutions and contribute to audits and SOPs.

Kenntnisse

Machine learning

AI agent development

Python

R

SAS

Clinical data

Real-world evidence

Survival analysis

Leadership

Regulatory guidance

Ausbildung

PhD or equivalent in Statistics/Biostatistics

Master's Degree in Statistics/Biostatistics

Tools

Microsoft Office

Jobbeschreibung

Edwards Lifesciences is seeking a Principal Biostatistician to drive machine learning and AI-driven analytics for clinical and real-world evidence projects. You will develop Python-based dashboards, apply causal inference methods, and guide analyses for Phase 4 studies and registries to support cross-functional teams.

You will mentor junior statisticians, contribute to SOPs and WIMs, and collaborate with stakeholders on regulatory submissions while ensuring data integrity and regulatory