Remote Principal Biostatistician - Cardiovascular Trials

Edwards Lifesciences; Boston (MA); Remote; USD 132,000 - 186,000; Full time

Benefits offered by this job

Competitive salary

Performance incentives

Comprehensive benefits

Job summary

Edwards Lifesciences in the United States is seeking a Principal Biostatistician to apply advanced statistics to support clinical research in cardiovascular therapies within the Transcatheter Mitral and Tricuspid Therapies unit.

You will lead analyses for multiple trials, collaborate with stakeholders on regulatory submissions, mentor junior statisticians, develop SOPs, and contribute to data monitoring and study documentation.

Qualifications

• Ph.D. or equivalent in Statistics/Biostatistics or related field with 2 years' experience
• Master's degree or equivalent in Statistics/Biostatistics with 5 years' experience in clinical trials (Required OR)
• Experience with regulatory submissions and statistical analyses in pharma/medical device context preferred

Responsibilities

• Lead statistical analyses for multiple clinical trials and study reports.
• Collaborate with stakeholders on NPD/regulatory submissions (PMA, CE Mark, PMDA).
• Mentor junior statisticians and coordinate project analysis timelines.
• Develop SOPs/WIMs and ensure audit readiness.

Skills

Statistical analysis

Clinical trial statistics

Leadership

Communication

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Tools

R

S-PLUS

CDISC SDTM/ADaM

MS Office

Job description

Edwards Lifesciences in the United States is seeking a Principal Biostatistician to apply advanced statistics to support clinical research in cardiovascular therapies within the Transcatheter Mitral and Tricuspid Therapies unit.

You will lead analyses for multiple trials, collaborate with stakeholders on regulatory submissions, mentor junior statisticians, develop SOPs, and contribute to data monitoring and study documentation.