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 from team members at all levels within the organization while cultivating innovation and influence change

Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions

Regularly interacts with executives and/or major customers while utilizing internal/ client-centric special skills for negation, balancing of stakeholders, managing ambiguity and influence for matters of significance to the organization

Proficiency in statistical programming language such as SAS and/or R required; Proven expertise in both Microsoft Office Suite

Expert understanding of analysis of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems; can ensure proper design, analysis, and presentation of pivotal clinical studies

Proven successful project management leadership skills including strict attention to detail

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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.

For California, the base pay range for this position is $208,000 to $295,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.