Remote Principal Biostatistician—Clinical Trials Leader

Edwards Lifesciences; Phoenix (AZ); Remote; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Principal Biostatistician to lead analyses for clinical trials, collaborate on regulatory submissions, and guide junior statisticians. You will implement advanced statistical methods, validate outputs, and contribute to SOP development in a fast‑paced, data‑driven environment.

PhD in Statistics/Biostatistics with 2+ years’ experience or a Master’s with 5+ years’ experience in clinical trials is required.

Qualifications

• Ph.D. or equivalent in Statistics, Biostatistics, or related field; 2 years’ experience
• Master's degree or equivalent in Statistics, Biostatistics, or related field; 5 years’ experience

Responsibilities

• Serve as statistical lead on multiple clinical trials and coordinate analyses
• Collaborate on regulatory submissions (PMA, CE Mark, PMDA) and related documents
• Mentor junior statisticians and manage project timelines and resources
• Develop and validate statistical methodologies and SOPs/WIMs
• Prepare technical documents for audits and ensure data integrity

Skills

Statistical leadership

R

Communication

Mentoring

Regulatory collaboration

Education

PhD in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

S-PLUS

MS Office

Job description

Edwards Lifesciences in Irvine, CA, seeks a Principal Biostatistician to lead analyses for clinical trials, collaborate on regulatory submissions, and guide junior statisticians. You will implement advanced statistical methods, validate outputs, and contribute to SOP development in a fast‑paced, data‑driven environment.

PhD in Statistics/Biostatistics with 2+ years’ experience or a Master’s with 5+ years’ experience in clinical trials is required.