EDWARDS LIFESCIENCES, Director, Biostatistics

Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance. Through clinical evidence we take our patient-focused innovations to improve the quality of our patient’s lives.

 

Key Responsibilities

  • Act as core team member and lead biostatistician of assigned clinical trials
  • Accountable for clinical trials assigned to direct reports
  • Manage and oversee the work of biostatistics team and may indirectly manage cross functional or matrix teams
  • 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