Remote Lead Biostatistician - Cardiovascular Trials

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

Job summary

Edwards Lifesciences in Irvine, CA seeks a Principal Biostatistician to lead statistical analyses for clinical trials and to support regulatory submissions. The role emphasizes hands-on analysis, methodological guidance, and collaboration with cross-functional teams.

Ideal candidates hold a PhD in Statistics or Biostatistics with relevant clinical trial experience and a track record in SDTM/ADaM standards, GCP, and regulatory interactions. Strong communication and leadership skills are essential.

Qualifications

• PhD in Statistics/Biostatistics with at least 2 years of analytical experience in clinical trials.
• MS in Statistics/Biostatistics with at least 5 years of analytical experience in clinical trials or equivalent.

Responsibilities

• Provide statistical leadership on multiple clinical trials and coordinate analyses for study reports.
• Collaborate with stakeholders to support NPD and regulatory submissions (PMA, CE Mark, PMDA).
• Represent Biostatistics on project teams and manage timelines and status communications.
• Advise on novel statistical methodologies and approaches for data analysis tasks.
• Prepare technical documents for internal and external audits and regulatory submissions.
• Contribute to SOPs, WIMs, and standardization of Biostatistics processes.
• Lead data analyses for data monitoring committees as needed.
• Mentor junior statisticians and assist with resource planning and budgeting.

Skills

R

S-PLUS

CDISC (SDTM/ADaM)

MS Office

Statistical leadership

Communication

Mentoring

Change management

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

S-PLUS

MS Office (Excel, Word, PowerPoint)

Job description

Edwards Lifesciences in Irvine, CA seeks a Principal Biostatistician to lead statistical analyses for clinical trials and to support regulatory submissions. The role emphasizes hands-on analysis, methodological guidance, and collaboration with cross-functional teams.

Ideal candidates hold a PhD in Statistics or Biostatistics with relevant clinical trial experience and a track record in SDTM/ADaM standards, GCP, and regulatory interactions. Strong communication and leadership skills are essential.