Lead Biostatistician - Clinical Trials & Regulatory

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 132,000 - 186,000; Full time

Benefits offered by this job

Competitive salaries

Incentives

Benefits programs

Job summary

Edwards Lifesciences, based in California, invites applications for a Principal Biostatistician within the Clinical Affairs team. You will apply rigorous statistics from trial design through regulatory submissions, collaborating with investigators, clinicians, and regulators to optimize patient outcomes.

You will lead analyses, contribute to SAPs, and ensure data quality while aligning with GCP/ICH guidelines.

Qualifications

• Ph.D. in Statistics, Biostatistics or related field required.
• At least 2 years of relevant clinical statistics experience.
• Strong communication and collaboration with cross‑functional teams.

Responsibilities

• Lead statistical analyses for clinical trials and coordinate study analyses.
• Support regulatory submissions and SOP development.
• Represent Biostatistics on project teams and manage timelines.

Skills

Survival analysis

SAS

R

Data quality assurance

Education

Ph.D. in Statistics/Biostatistics

Tools

SAS

R

S-Plus

MS Office

Job description

Edwards Lifesciences, based in California, invites applications for a Principal Biostatistician within the Clinical Affairs team. You will apply rigorous statistics from trial design through regulatory submissions, collaborating with investigators, clinicians, and regulators to optimize patient outcomes.

You will lead analyses, contribute to SAPs, and ensure data quality while aligning with GCP/ICH guidelines.