• Manager, Biostatistics - Transcatheter Mitral & Tricuspid Therapies

    Edwards LifesciencesIrvine, CA 92604

    Job #1078955034

  • This is an exciting opportunity for an exceptional biostatistician professional with significant experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives.

    The Manager, Biostatistics will be responsible for a team of biostatisticians and activities while ensuring the proper design, analysis, and presentation of clinical studies.

    Essential Job Functions / Key Responsibilities:

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

    • Manage and oversee the work of a small biostatistics team and may indirectly manage cross functional or matrix teams as appropriate

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

    • Provide statistical insight/strategies to study design for complex clinical studies

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

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

    • 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

    • Manage activities with accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams

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

    • Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities

    • Other incidental duties

    Basic Qualifications and Minimum Requirements:

    • Master's Degree in Statistics or Biostatistics, with 7 years of previous analytical experience in clinical trials, or

    • Ph.D. in Statistics or Biostatistics, with 4 years of previous analytical experience in clinical trials

    • Proficiency in a statistical programming language such as SAS and R

    • Proven successful project management leadership skills

    • Proven expertise in Microsoft Office Suite

    • Proven track of successful experience in NDA/IDE/PMA/PMDA/CE mark submissions

    • Expert 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 manage assigned team 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

    • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

    • Capable of independently leading pivotal trials

    • Experience using PASS or EAST

    • Experience in trial simulations for sample size and power calculation

    • DMC/DSMB experience

    • Familiar with survival, regression and categorical data analysis methods

    Preferred Qualifications:

    • Medical Device experience

    • Adaptive design experience

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

    • Promote a culture of collaboration and teamwork

    • Strict attention to detail

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

    • Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

    Additional Talents and General Expectations:

    • Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team

    • Participate and present at meetings with internal and external representatives

    • Resolve operational and scheduling issues

    • Dedicated to quality client service and proactive and responsive to client needs

    • Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness

    • Develop relationships and leverage them to influence change

    • Support and solicit input from team members at all levels within the organization

    The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don't miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.

    #LI-GT1 #MI

    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 13,000 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.