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