Director, Biostatistics

Edwards Lifesciences • Irvine, CA

4d • $205,000 - $255,000 • Remote

About The Position

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. You will make an impact by... 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

Requirements

• 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

Nice To Haves

• 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

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

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees