Senior Biostatistician – Cardiovascular Trials Leader

Edwards; Irvine (CA); Hybrid; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Principal Biostatistician to lead advanced analyses for clinical research within our Medical Affairs team. You will apply statistical methods, interpret results, and support regulatory submissions in a data-driven environment.

The role requires a Ph.D. or equivalent in statistics with extensive experience, expertise in R, and strong communication skills to work with cross-functional teams.

Qualifications

• Ph.D. or equivalent in Statistics/Biostatistics with 2 years’ experience.
• MS in Statistics/Biostatistics with 5 years’ analytical clinical trials experience.
• Proven expertise in statistical programming and data analysis in clinical research.

Responsibilities

• Statistical lead on multiple clinical analyses and study reports.
• Provide programming and validation support for analyses.
• Collaborate with stakeholders on regulatory submissions (PMA, CE Mark, PMDA).
• Mentor junior statisticians and contribute to SOPs and WIMs.
• Interpret results and communicate with management and cross-functional teams.

Skills

Leadership

Communication

Analytical thinking

Mentoring

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Tools

R

S-PLUS

Excel

Word

PowerPoint

Access

Job description

Edwards Lifesciences in Irvine, CA, is seeking a Principal Biostatistician to lead advanced analyses for clinical research within our Medical Affairs team. You will apply statistical methods, interpret results, and support regulatory submissions in a data-driven environment.

The role requires a Ph.D. or equivalent in statistics with extensive experience, expertise in R, and strong communication skills to work with cross-functional teams.