Remote Principal Biostatistician: Cardiovascular Trials

Edwards Lifesciences Gruppe; Olympia (WA); Remote; USD 132,000 - 186,000; Full time

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician to lead statistical analysis for clinical trials, provide expert guidance, and support regulatory submissions. This role emphasizes collaboration with cross-functional teams and adherence to regulatory standards in a remote-capable setup.

The ideal candidate holds a Ph.D. in statistics or biostatistics with several years of trial experience, strong R expertise, and familiarity with CDISC SDTM/ADaM.

Qualifications

• Ph.D. or equivalent in Statistics/Biostatistics or related field; 2 years' experience.
• Master's degree or equivalent in Statistics/Biostatistics or related field; 5 years' experience in analytical clinical trial work.

Responsibilities

• Statistical lead on multiple clinical trials and analysis coordination.
• Collaborate with stakeholders for statistical support in NPD and regulatory submissions (PMA, CE Mark, PMDA).
• Represent Biostatistics on project teams and communicate status and timelines.

Skills

R

Statistical software

MS Office

Communication

Leadership

Problem-solving

Regulatory knowledge

Training coaching

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Tools

S-PLUS

CDISC SDTM/ADaM

Job description

Edwards Lifesciences is seeking a Principal Biostatistician to lead statistical analysis for clinical trials, provide expert guidance, and support regulatory submissions. This role emphasizes collaboration with cross-functional teams and adherence to regulatory standards in a remote-capable setup.

The ideal candidate holds a Ph.D. in statistics or biostatistics with several years of trial experience, strong R expertise, and familiarity with CDISC SDTM/ADaM.