Senior Director, Biostatistics

Senior Director, Biostatistics – Transcatheter Heart Valve

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

As the Senior Director of Biostatistics, THV, you will be responsible for direct management of biostatistics teams and activities while providing overall management of statistics globally.  In this role, you within THV.

This position is office based on our beautiful campus in Irvine, California. We will support relocation costs for relocation if needed.

How you will make an impact:

• Be the lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams

• Directing biostatistics activities with overall responsibility of managing vendors, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through several managers and/or SMEs

• Developing robust talent development and succession planning in alignment with functional growth strategies across the global biostatistics organization to build and/or maintain an effective team across the organization

• Providing strategic clinical and statistical leadership to entire portfolio of business unit in collaboration with cross-functional areas (e.g., Clinical Affairs, Medical Affairs)

• Mitigating/eliminating risk while directing and communicating highly complex biostatistics strategies which include negotiations with internal and external parties

• Analyzing, formulating and presenting statistical recommendations to advise and guide executive level leadership; develop and delivery of executive level communication

• Providing guidance on process improvement projects within biostatistics and cross-functional areas

• Creating, maintaining, and implementing SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization

• Planning and direct strategic activities including prioritizing as well as allocating resources for projects with overall responsibility for meeting business objectives

• Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics &Reimbursement)

• Other incidental duties

What you will need (Required)

• Ph.D. or Master's Degree or equivalent in Statistics, Biostatistics, or related field

• Proven proficiency in statistical knowledge and skills including expert understanding of complex biostatistics methodologies, processes and/or systems Required

• Excellent communication skills to drive meetings with Key Opinion Leaders, Physicians and Regulators Required

• Skill levels exceeding the requirements of the Sr Manager Required

What else we look for (Strongly Preferred):

In addition to meeting the basic requirements listed above, we strongly prefer candidates who possess these critical skills and background listed below that will help us achieve our urgent business goals.

• Ability to manage people and excel within a fast paced, dynamic, and changing work environment by utilizing learned change-management techniques as well as strategic & broad perspective

• Demonstrated ability to promote a culture of collaboration and teamwork including relationship development with peers, cross functional partners and cross BUs to maximize best practice sharing and team effectiveness

• Demonstrated ability to direct teams and provide coaching and feedback; including responsibility for all employee actions including hire/fire authority, proactively escalate issues, and partnering with HR on all aspects of employee relations

• Excellent written and verbal communication skills and interpersonal relationship skills; Proven capability to conduct business and technical briefings to internal & external stakeholders

• Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions

• Support and solicit input f