Senior Biostatistician - Clinical Trials & Regulatory Lead

Edwards Lifesciences Gruppe; California; Hybrid; USD 132,000 - 186,000; Full time

Benefits offered by this job

Competitive salary

Incentives and benefits programs

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician to lead analysis efforts in clinical trials and support regulatory submissions. You will apply advanced biostatistical methods, mentor junior staff, and collaborate with cross-functional teams in a highly data-driven environment.

The role requires a Ph.D. or equivalent in Statistics/Biostatistics with substantial experience, and expertise in CDISC standards, R, and regulatory guidelines. Strong communication and leadership are essential.

Qualifications

• Ph.D. or equivalent in Statistics/Biostatistics or related field with 2 years' experience.
• Master's degree in Statistics/Biostatistics or related field with 5 years' experience.

Responsibilities

• Serve as Statistical lead on multiple clinical trials and coordinate analyses.
• Provide statistical expertise for NPD and regulatory submissions (PMA, CE Mark, PMDA).
• Represent Biostatistics on project teams and communicate status and timelines.
• Research and recommend novel statistical methodologies.
• Provide guidance on ad hoc data analyses and publications.
• Prepare technical documents for audits and SOPs/WIMs.

Skills

R programming

Leadership

Communication

Education

Ph.D. in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

S-PLUS

CDISC SDTM/ADaM

MS Office (Word/Excel)

Job description

Edwards Lifesciences is seeking a Principal Biostatistician to lead analysis efforts in clinical trials and support regulatory submissions. You will apply advanced biostatistical methods, mentor junior staff, and collaborate with cross-functional teams in a highly data-driven environment.

The role requires a Ph.D. or equivalent in Statistics/Biostatistics with substantial experience, and expertise in CDISC standards, R, and regulatory guidelines. Strong communication and leadership are essential.