Lead Biostatistician, Cardiovascular Clinical Trials

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

Benefits offered by this job

Competitive base salary

Performance-based incentives

Comprehensive benefits

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Principal Biostatistician to apply advanced biostatistical methods to clinical data, lead analyses, and support regulatory submissions. You will mentor junior statisticians and shape SOPs and WIMs in a data-driven environment.

You will collaborate with cross-functional teams to inform product development strategies, ensure analytical rigor, and contribute to audits and reports for internal and external stakeholders.

Qualifications

• Ph.D. or equivalent in Statistics/Biostatistics with 2 years' experience OR
• Master's degree in Statistics/Biostatistics with 5 years' experience in clinical trials

Responsibilities

• Lead statistical analyses for multiple clinical trials and coordinate analyses for study reports
• Collaborate with stakeholders to support NPD and regulatory submissions (PMA, CE Mark, PMDA)
• Represent Biostatistics on project teams and communicate status and timelines
• Develop and validate TLF shells and contribute to study documentation

Skills

R

MS Office

Leadership

Regulatory knowledge

Statistical methodologies

Education

Ph.D. in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

S-PLUS

CDISC SDTM/ADaM

Job description

Edwards Lifesciences in Irvine, CA is seeking a Principal Biostatistician to apply advanced biostatistical methods to clinical data, lead analyses, and support regulatory submissions. You will mentor junior statisticians and shape SOPs and WIMs in a data-driven environment.

You will collaborate with cross-functional teams to inform product development strategies, ensure analytical rigor, and contribute to audits and reports for internal and external stakeholders.