Lead Biostatistician — Cardiovascular Clinical Trials

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

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Principal Biostatistician to lead statistical analyses for multiple clinical trials and support regulatory submissions. You will implement methodologies, validate outputs, and mentor junior statisticians within a data-driven environment.

The role requires advanced statistical expertise, strong collaboration with stakeholders, and a focus on high-quality deliverables in line with GCP and FDA guidelines.

Qualifications

• Ph.D. in Statistics, Biostatistics or related field with relevant experience.
• Advanced experience in clinical trial data and regulatory submissions.
• Strong communication and leadership skills for cross-functional teams.
• Proficiency in CDISC standards and regulatory guidelines.

Responsibilities

• Statistical lead on multiple clinical trials with analysis coordination.
• Provide statistical expertise for NPD and regulatory submissions.
• Represent Biostatistics on project teams and communicate timelines.
• Mentor junior statisticians and contribute to SOPs and WIMs.

Skills

R

CDISC

MS Office

Statistical modeling

Education

Ph.D. in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

S-PLUS

SDTM

Job description

Edwards Lifesciences in Irvine, CA, seeks a Principal Biostatistician to lead statistical analyses for multiple clinical trials and support regulatory submissions. You will implement methodologies, validate outputs, and mentor junior statisticians within a data-driven environment.

The role requires advanced statistical expertise, strong collaboration with stakeholders, and a focus on high-quality deliverables in line with GCP and FDA guidelines.