Senior Biostatistician - Cardiovascular Trials Lead

Edwards Lifesciences Belgium; Atlanta (GA); On-site; USD 132,000 - 186,000; Full time

Benefits offered by this job

Benefits programs

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician in Irvine, CA to lead statistical analyses for clinical trials and provide expert support for regulatory submissions. You will collaborate with cross-functional teams to ensure data integrity and robust statistical conclusions.

The role requires a PhD in Statistics/Biostatistics with 2+ years (or an MS with 5+ years) of relevant experience, expertise in R, and knowledge of CDISC SDTM/ADaM standards.

Qualifications

• Ph.D. in Statistics, Biostatistics, or related field with 2+ years of experience.
• Master’s in Statistics/Biostatistics with 5+ years of analytical experience in clinical trials (required or alternative).

Responsibilities

• Lead statistical analyses for multiple clinical trials and support study reports.
• Collaborate with stakeholders on new product development and regulatory submissions (e.g., PMA, CE Mark).
• Mentor junior statisticians and contribute to SOPs and process improvements.

Skills

R

Statistical thinking

Data analysis

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

S-PLUS

MS Office

Job description

Edwards Lifesciences is seeking a Principal Biostatistician in Irvine, CA to lead statistical analyses for clinical trials and provide expert support for regulatory submissions. You will collaborate with cross-functional teams to ensure data integrity and robust statistical conclusions.

The role requires a PhD in Statistics/Biostatistics with 2+ years (or an MS with 5+ years) of relevant experience, expertise in R, and knowledge of CDISC SDTM/ADaM standards.