Principal Biostatistician - Cardiovascular Trials Lead

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician to lead statistical analyses for multiple clinical trials and support regulatory submissions, ensuring robust, data-driven decisions. The role involves collaborating with stakeholders, mentoring junior statisticians, and shaping Biostatistics SOPs in a highly regulated medical device environment.

Ideal candidates hold a Ph.D. or equivalent with several years of trial experience, strong expertise in R and CDISC standards, and proven

Qualifications

• Ph.D. or equivalent in Statistics/Biostatistics, 2 years’ experience.
• Master's in Statistics or Biostatistics, 5 years analytical experience in clinical trials.

Responsibilities

• Statistical lead on multiple clinical trials and analyses for study reports.
• Collaborate on regulatory submissions (PMA, CE Mark, PMDA) with statistical support.
• Represent Biostatistics on project teams and communicate status and timelines.
• Propose novel statistical methods and provide guidance on ad hoc analyses.
• Mentor junior statisticians and contribute to budget/timeline planning.
• Develop and improve SOPs and WIMs for Biostatistics processes.

Skills

R

CDISC Standards

Statistical modeling

Regulatory knowledge

Leadership

Education

Ph.D. in Statistics/Biostatistics

Master's in Statistics

Tools

R

S-PLUS

MS Office

Job description

Edwards Lifesciences is seeking a Principal Biostatistician to lead statistical analyses for multiple clinical trials and support regulatory submissions, ensuring robust, data-driven decisions. The role involves collaborating with stakeholders, mentoring junior statisticians, and shaping Biostatistics SOPs in a highly regulated medical device environment.

Ideal candidates hold a Ph.D. or equivalent with several years of trial experience, strong expertise in R and CDISC standards, and proven