Principal Biostatistician — Lead Clinical Trial Analytics

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences Irvine seeks a Principal Biostatistician to lead statistical analyses across multiple clinical trials, shaping evidence for cardiovascular therapies.

You will collaborate with cross-functional teams, develop novel methods, and contribute to regulatory submissions while mentoring junior statisticians. A PhD or equivalent with 2 years of trial analytics, or a Master’s with 5 years, is required; expertise in CDISC SDTM/ADaM and R is preferred.

Qualifications

• PhD or equivalent in Statistics/Biostatistics; 2 years of clinical analytics experience.
• Master's in Statistics/Biostatistics; 5 years of analytical experience in clinical trials.

Responsibilities

• Lead statistical analyses for multiple clinical trials.
• Coordinate analyses for study reports and audit deliverables.
• Provide programming and validation support for analyses.
• Collaborate with stakeholders on regulatory submissions (PMA/CE).
• Mentor junior statisticians and support management planning.

Skills

R programming

CDISC standards

Statistical modeling

Clinical trials

Leadership

Education

PhD in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

S-PLUS

MS Office Suite

Job description

Edwards Lifesciences Irvine seeks a Principal Biostatistician to lead statistical analyses across multiple clinical trials, shaping evidence for cardiovascular therapies.

You will collaborate with cross-functional teams, develop novel methods, and contribute to regulatory submissions while mentoring junior statisticians. A PhD or equivalent with 2 years of trial analytics, or a Master’s with 5 years, is required; expertise in CDISC SDTM/ADaM and R is preferred.