Edwards Lifesciences Senior Manager, Biostatistics – Transcatheter Mitral & Tricuspid Therapies in Irvine, California

This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. We are seeking talented Clinical professionals to become part of a fast-paced, dynamic team and play a pivotal role in the development of new therapies and devices, from concept through to human use.

Reporting to Director of Biometrics, the Sr. Manger of Biostatistics will provide leadership to a team of Biostatisticians in a fast paced and growing environment. The ideal candidate is dynamic, driven, experienced in clinical trial design, application of novel statistical methods, quality assurance as well as people management experiences.

Key responsibilities:

  • Manage and oversee the work of a biostatistics team and have financial budget responsibilities.

  • Develop a robust talent development plan in alignment with functional growth strategies of the department.

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

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

  • Act as core team member/lead biostatistician of assigned clinical trial(s). Accountable for clinical trials assigned to direct reports

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

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

  • Plan and manage complex activities with large scale and significant business impact with 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 matrixed teams

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

  • Provide resource analysis and planning for biostatistics functions

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Qualifications:

Qualifications

Education and Experience:

PhD Degree in Statistics, Biostatistics, or related field, with a minimum of 8 years of experiences in the device, biopharma, or medical research organizations.

OR

Master‘s degree of equivalent in Statistics, Biostatistics, or related analytical field; with minimum of 10 years of experiences in the device, biopharma, or medical research organizations.

Required skills:

  • Proficiency in statistical programming language such as SAS and/or R required.

  • Excellent written and verbal communication skills andinterpersonal relationship skills

  • Keeps abreast of new developments in statistics andregulatory guidance

  • Expert understanding and knowledge in statisticalmethodologies related to clinical trial designs, statistical modeling anddata analyses; and be able to efficiently communicate statisticalconcepts, approaches, or results to internal/external stakeholders

  • Excellent problem-solving, organizational, analyticaland critical thinking skills

  • Ability to manage competing priorities in a fast pacedenvironment

  • Ability to provide training and coaching to juniorlevel employees

About Edwards

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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.

Title: Senior Manager, Biostatistics – Transcatheter Mitral & Tricuspid Therapies Location: USA-USA-California - Irvine Job Number: 013720