Lead Biostatistician, Cardiovascular Trials & Analytics

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

Job summary

Edwards Lifesciences is seeking a Principal Biostatistician in Irvine, CA to lead statistical analyses for clinical trials and support regulatory submissions. The role involves collaboration with cross-functional teams, mentoring junior statisticians, and contributing to SOPs and data governance.

The candidate should have a PhD or equivalent in statistics/biostatistics with significant clinical trials experience, strong R skills, and familiarity with GCP/ICH/FDA guidelines.

Qualifications

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience of experience
• Master's Degree or equivalent in Statistics, Biostatistics, or related field, 5 years’ experience of previous analytical experience in clinical trials Required OR

Responsibilities

• Statistical lead on multiple clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses
• Collaborate with core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
• Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
• Research and recommend novel statistical methodology and/or approaches Provide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project team
• Compile technical documents for internal and external audits
• Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)
• Lead the efforts of data analysis for data monitoring committee as needed
• Mentor Junior statisticians and work with management in resource allocation and budget/timeline development activities

Skills

Statistical lead

R

MS Office Suite

Regulatory guidance (GCP/ICH/FDA/ISO)

Data analysis & interpretation

Collaboration & communication

Mentoring junior statisticians

Education

Ph.D. in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

S-PLUS or analytics tools

Job description

Edwards Lifesciences is seeking a Principal Biostatistician in Irvine, CA to lead statistical analyses for clinical trials and support regulatory submissions. The role involves collaboration with cross-functional teams, mentoring junior statisticians, and contributing to SOPs and data governance.

The candidate should have a PhD or equivalent in statistics/biostatistics with significant clinical trials experience, strong R skills, and familiarity with GCP/ICH/FDA guidelines.