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Edwards Lifesciences Sr Manager, Biostatistics - Transcatheter Heart Valve in Irvine, California

As the Senior Manager, Biostatistician, you will be responsible for a team of Biostatisticians, along with activities to ensure the proper design, analysis, and presentation of clinical studies for our Transcatheter Heart Valve (THV) business unit.

Joining Edwards Lifesciences means innovating, pushing boundaries and being creative while always putting patients first. It means solving challenges with colleagues who share your sense of urgency, optimism, and passion, colleagues who are just as passionate about testing their limits and taking ownership. And it means that you will be empowered to get the job done by taking charge of your work, your health, and your career.

Innovation is at the core of Edwards! Without it, we would not be able to produce the life-saving products and therapies that transform lives around the world. That is why we surround ourselves with people who are not afraid to question the status quo or express a different point of view. Employees who feel passionate about the Edwards credo and dedication to community.

Job Functions:

  • Lead and coordinate the work of a biostatistics team and have financial budget responsibilities

  • Provide technical, statistical leadership and strategic input to multiple and/or complex clinical projects and programs in collaboration with cross-functional teams

  • Accountable for clinical trials assigned to direct reports

  • Develop a robust talent development plan in alignment with functional growth strategies of the department and promote a culture of collaboration and partnership

  • Develop and lead in the implementation of broad and more complex biostatistics strategies which may include negotiations with internal and external parties

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

  • Provide mentorship on process improvement projects within biostatistics and cross-functional areas

  • Build, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization

  • Plan and lead complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables

  • Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams

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

  • Provide resource analysis and planning for biostatistics functions

  • Frequently interacts with internal and external management and senior-level partners concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications

  • Lead briefings and technical meetings for internal and external representatives

Basic Qualifications:

  • A Master's Degree in Statistics, Biostatistics, or related field with a minimum of 11 years experience OR a Ph.D. and a minimum of 8 years experience of analytical experience in clinical trials is required

  • A minimum of 2 years leadership experience required

  • Proficiency in SAS required

  • Knowledge of theoretical and applied statistics is required

  • Understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting is required

  • Ability to travel up to 10%

Preferred Qualifications:

  • Experience in Bayesian Analysis is strongly preferred

  • Proficiency in R is preferred

  • Proven successful project management leadership skills

  • Proven expertise in both Microsoft Office Suite

  • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

  • Experienced understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems

  • Expert understanding of related aspects of biostatistics processes and/or systems

  • Demonstrated ability to lead one or more teams and provide mentoring and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels and proactively advance issues to appropriate levels of management in the organization

  • Ability to work and excel within a fast paced, multifaceted, and constantly evolving work environment

  • Requires the ability to change the thinking of, or gain acceptance from others in critical situations, without damage to the relationship

  • Dedicated to quality client service and pro-active and responsive to client needs

  • Enforce to all EHS rules and requirements 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

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

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.