Edwards Lifesciences · 6 days ago
Principal Biostatistician
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$129K/yr - $182K/yr
2+ years expEdwards Lifesciences is a company dedicated to transforming patient lives through clinical evidence and innovative technologies. The Principal Biostatistician will lead statistical analyses for clinical trials and collaborate with stakeholders to support new product development and regulatory submissions.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Statistical lead on one or more 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 new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
Provide statistical expertise 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)
Collaborate on developing case report forms and clinical database to ensure quality data collection
Lead the efforts of data analysis for data monitoring committee as needed
Qualification
Required
Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience
Preferred
Survival analysis experience
Proven expertise in SAS
Experience using other software packages (e.g., R, S-Plus)
Statistical Analysis Plans (SAP)
Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Keeps abreast of new developments in statistics and regulatory guidance
Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
2026-01-13
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