Edwards Lifesciences · 5 hours ago
Principal Biostatistician
United States
Full-time
Remote
Senior Level, Lead/Staff
$129K/yr - $182K/yr
2+ years expEdwards Lifesciences is dedicated to improving patient lives through innovative solutions in cardiovascular care. The Principal Biostatistician will lead statistical analyses for clinical trials and collaborate with stakeholders on regulatory submissions, ensuring the application of scientific rigor to statistical methods and data quality assurance.
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
Training or publications in Bayesian methodology
Expertise in MS Office (Word, PowerPoint, Access, Excel)
Strong written/verbal communication and relationship management skills
Up-to-date on statistical and regulatory developments
Deep knowledge of clinical trial design, statistical modeling, and data analysis
Proficient in SAS; experience with R, S-Plus
Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices
Excellent problem-solving, analytical, and critical thinking skills
Proven leadership and ability to influence change
Skilled in training/coaching and facilitating organizational change
Detail-oriented; able to manage competing priorities in fast-paced environments
Professional interaction across all levels; collaborative team player and consultant to management
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
2025-12-25
Medical Device Network
2025-12-25
Company data provided by crunchbase