Edwards Lifesciences · 3 hours ago
Director, Biostatistics
Irvine, CA
Full-time
Hybrid
Director/Executive
$205K/yr - $255K/yrEdwards Lifesciences is focused on generating clinical evidence to demonstrate the effectiveness and safety of their innovations. The Director of Biostatistics will lead a team of biostatisticians to shape clinical study design and data analysis, driving new product innovation and optimizing patient outcomes.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Leading a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation
Providing technical and strategic leadership for multiple complex clinical programs, collaborating with cross-functional teams
Overseeing the biostatistics team, managing budgets to maximize research impact
Defining statistical methodologies and real-world evidence strategies, influencing research publications and regulatory success
Acting as the lead biostatistician for assigned clinical trials, ensuring statistical integrity and meaningful insights
Developing and implementing talent development plans, fostering leadership within the biostatistics team
Driving complex biostatistics strategies, engaging with both internal and external stakeholders
Spearheading process improvement initiatives to enhance efficiency across biostatistics and cross-functional areas
Establishing and optimizing SOPs, processes, and standards to ensure accuracy and compliance
Managing high-impact activities, proactively addressing risks and resolving issues collaboratively
Providing statistical expertise to key stakeholders, including marketing, health economics, and reimbursement teams
Overseeing resource analysis and planning, ensuring optimal support for biostatistics functions
Ensuring clinical trial integrity and success for direct reports and assigned studies
Contributing to additional initiatives that shape the future of medical device development
Qualification
Required
Ph.D. or equivalent in Statistics, Biostatistics, or related with previous analytical experience in clinical trials
Demonstrated ability to manage one or more teams and provide and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Preferred
Proven leadership managing teams and projects, driving innovation, excellence, and successful delivery of complex initiatives
Extensive biostatistical experience applying complex methodologies and analyzing clinical trials data
Deep expertise in clinical trial design and statistical methodology, solving complex challenges and driving innovation
Extensive experience on publications and real-world evidence generation, ensuring meaningful impact in clinical outcomes
Strategic understanding of biostatistics processes and systems, enabling optimal application across multiple projects
Exceptional communication and negotiation skills, leveraging data-driven insights to influence decision-making
Proven ability to coach, support, and manage direct reports across all aspects of employee relations
Meticulous attention to detail ensuring accuracy, compliance, and integrity in statistical analyses and reporting
Professional presence across all organizational levels, proactively addressing and escalating issues as needed
Ability to thrive in fast-paced, dynamic environments and adapt to evolving priorities
Regular engagement with senior stakeholders to shape operational decisions and influence strategic direction
Lead technical meetings and briefings, collaborating with internal and external representatives to drive initiatives forward
Build strong relationships and cross-functional partnerships, establishing best practices and advancing global enterprise systems
Commitment to quality client service, responding proactively to stakeholder needs and challenges
Key role in influencing organizational change, leveraging relationships and insights to drive transformation
Strong change leadership skills, capable of driving consensus in complex or sensitive situations
Expertise in statistical programming (SAS and/or R) for advanced clinical analyses and impactful research
Strong proficiency in Microsoft Office Suite to support analytical and reporting functions
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.
Founded in 1958
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
Company data provided by crunchbase