Lead Biostatistician, Cardiovascular Trials

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits package

Job summary

Edwards Lifesciences in Irvine, CA seeks a Principal Biostatistician to apply advanced biostatistical methods across clinical trials and regulatory submissions. You will implement methodologies, generate results, and guide data-driven decision-making in a highly collaborative environment.

Responsibilities include leading analyses, coordinating study reports, and mentoring junior statisticians while ensuring compliance with GCP, ICH, FDA, and ISO standards.

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 clinical trials required.

Responsibilities

• Statistical lead on multiple clinical trials, coordinate analyses for study reports and provide programming and validation support.
• Collaborate with core stakeholders to provide statistical expertise for multiple NPD and/or regulatory submissions (e.g., PMA, CE Mark, PMDA).
• Represent Biostatistics on project teams and coordinate with management on status and timelines.
• Research and recommend novel statistical methodologies and provide guidance on ad hoc analyses and publications.
• Prepare technical documents for audits and regulatory submissions.
• Contribute to Biostatistics SOPs and Work Instruction Manuals development.
• Lead data analysis efforts for data monitoring committees as needed.
• Mentor junior statisticians and support budget/timeline planning.

Skills

R proficiency

Statistical modeling

Leadership

Communication

Regulatory knowledge

Education

Ph.D. in Statistics/Biostatistics

M.S. in Statistics/Biostatistics

Tools

R

S-PLUS

CDISC SDTM

CDISC ADaM

MS Office

Job description

Edwards Lifesciences in Irvine, CA seeks a Principal Biostatistician to apply advanced biostatistical methods across clinical trials and regulatory submissions. You will implement methodologies, generate results, and guide data-driven decision-making in a highly collaborative environment.

Responsibilities include leading analyses, coordinating study reports, and mentoring junior statisticians while ensuring compliance with GCP, ICH, FDA, and ISO standards.