This is a unique opportunity for an experienced statistician to join the biostatistical group in Edwards Lifesciences Transcatheter Heart Valve business unit to support various global clinical activities. This is a fast-paced, dynamic team working on innovative medical devices. The individual in this position will have opportunities in generating evidence from various clinical trial data and real world data (RWD).The Senior Biostatistician participates in the planning and execution of statistical projects under guidance from management or more senior level statistician.

The Senior Biostatistician participates in the planning and execution of statistical projects under guidance from management or more senior level statistician.

Key Responsibilities

• Provide support in study design and endpoints development, including randomization scheme when appropriate
• Develop Statistical Analysis Plans (SAPs) and support statistical execution for clinical trials
• Review protocols and contribute to statistical aspects in the protocol
• Provide statistical support for  clinical study reports (CSRs), global regulatory reports, global regulatory submissions, and in response to regulatory questions
• Collaborate effectively with clinical data managers and statistical programmers to support trials and projects
• Provide statistical support for podium presentations and peer reviewed publications
• Work with cross-functional teams to ensure results are presented accurately and clearly
• Keep abreast of new developments in statistics, device & drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
• Generate internal report for Biostatistics management or above
• Propose and present statistical issues, process, and methodology to biostatistics colleagues, non-biostatisticians, and cross-functional teams