Senior Biostatistician, Cardiovascular Trials Lead

Edwards Lifesciences Belgium; Santa Fe (NM); On-site; USD 132,000 - 186,000; Full time

Benefits offered by this job

Competitive salary

Performance-based incentives

Comprehensive benefits

Job summary

Edwards Lifesciences Belgium seeks a Principal Biostatistician to apply advanced statistical methods to clinical data, guiding analyses that influence regulatory submissions and strategic decisions in the TMTT portfolio.

You will lead analyses for multiple trials, collaborate with cross-functional teams, and mentor junior statisticians while ensuring data integrity and auditable processes in a highly regulated environment.

Qualifications

• Ph.D. in Statistics or Biostatistics with relevant clinical trials experience.
• Master’s degree with substantial analytical experience in clinical trials is acceptable.
• Experience with regulatory submissions and data standardization is preferred.

Responsibilities

• Statistical lead on multiple clinical trials and study analyses.
• Provide programming, validation, and interpretation of analyses.
• Collaborate with stakeholders on NPD/regulatory documents (PMA, CE Mark).
• Mentor junior statisticians and coordinate timelines/budgets.
• Develop SOPs/WIMs and contribute to audit-ready documentation.

Skills

Statistical leadership

Ad hoc data analysis

Communication skills

Training/coaching

Regulatory understanding

Education

Ph.D. in Statistics/Biostatistics or related field

Master’s in Statistics/Biostatistics or related field

Tools

R

CDISC SDTM/ADaM

MS Office Suite

Job description

Edwards Lifesciences Belgium seeks a Principal Biostatistician to apply advanced statistical methods to clinical data, guiding analyses that influence regulatory submissions and strategic decisions in the TMTT portfolio.

You will lead analyses for multiple trials, collaborate with cross-functional teams, and mentor junior statisticians while ensuring data integrity and auditable processes in a highly regulated environment.