Principal Biostatistician — Cardiovascular Trials Lead

Edwards Lifesciences Belgium; Montpelier (VT); 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, interpret results, mentor junior staff, and contribute to SOPs and systematic processes in a data-driven environment.

The role requires a Ph.D. or equivalent in Statistics/Biostatistics with substantial clinical trial analytics experience, plus expertise in R and CDISC standards.

Qualifications

• Ph.D. in Statistics, Biostatistics, or related field.
• Master's degree in Statistics, Biostatistics, or related field; 5 years’ experience in analytical work in clinical trials.

Responsibilities

• Statistical lead on multiple clinical trials and coordinate analyses.
• Provide programming and validation support for analyses.
• Collaborate with stakeholders on NPD/regulatory submissions and documents.
• Represent Biostatistics on project/study teams and report progress.
• Research novel statistical methodologies and guide ad hoc analyses.
• Contribute to audits, SOPs, and standard work documents.
• Lead data analysis for data monitoring committees as needed.
• Mentor junior statisticians and support budget/timeline planning.

Education

Ph.D. in Statistics/Biostatistics

Master's degree in Statistics/Biostatistics

Tools

R

S-PLUS

CDISC SDTM/ADaM

MS Office Suite (Word, PowerPoint, Excel)

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, interpret results, mentor junior staff, and contribute to SOPs and systematic processes in a data-driven environment.

The role requires a Ph.D. or equivalent in Statistics/Biostatistics with substantial clinical trial analytics experience, plus expertise in R and CDISC standards.