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Senior Biostatistics and Clinical Operations Director

2 months ago


San Bernardino, California, United States Edwards Lifesciences Full time
About the Role

Edwards Lifesciences is seeking a highly skilled Senior Director, Biostatistics and Clinical Leadership to join our team. As a key member of our organization, you will be responsible for leading biostatistics teams and activities, providing overall management of statistics globally, and driving business growth through data-driven insights.

Key Responsibilities
  • Biostatistics Leadership: Direct management of biostatistics teams and activities, including vendor management, planning, staffing, budgeting, and expense prioritization.
  • Statistical Expertise: Provide strategic clinical and statistical leadership to our business unit, collaborating with cross-functional areas such as Clinical Affairs and Medical Affairs.
  • Risk Mitigation: Identify and develop complex mitigation strategies, best practices, and alternative solutions to resolve issues and drive business growth.
  • Talent Development: Develop and implement robust talent development and succession planning strategies to build and maintain an effective team across the organization.
  • Communication: Analyze, formulate, and present statistical recommendations to advise and guide executive-level leadership, and develop and deliver executive-level communication.
  • Process Improvement: Provide guidance on process improvement projects within biostatistics and cross-functional areas, and create, maintain, and implement SOPs, processes, standards, and work instructions.
  • Project Management: Plan and direct strategic activities, including prioritizing and allocating resources for projects, and ensuring meeting of business objectives.
  • Stakeholder Engagement: Provide statistical expertise to internal and external stakeholders, including presentation, publication, marketing, and health economics and reimbursement.
Requirements
  • Education: Ph.D. or Master's Degree or equivalent in Statistics, Biostatistics, or related field.
  • Experience: Proven proficiency in statistical knowledge and skills, including expert understanding of complex biostatistics methodologies, processes, and systems.
  • Communication: Excellent communication skills to drive meetings with Key Opinion Leaders, Physicians, and Regulators.
  • Leadership: Skill levels exceeding the requirements of the Sr. Manager, with ability to manage people and excel within a fast-paced, dynamic, and changing work environment.
Preferred Qualifications
  • Change Management: Ability to manage change and promote a culture of collaboration and teamwork.
  • Coaching and Feedback: Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions.
  • Communication: Excellent written and verbal communication skills and interpersonal relationship skills.
  • Leadership: Ability to provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions.
  • Statistical Programming: Proficiency in statistical programming language such as SAS and/or R, and proven expertise in Microsoft Office Suite.
About Edwards Lifesciences

Edwards Lifesciences is a global leader in patient-focused medical innovations for cardiac and critical care markets. We are committed to improving the lives of patients and healthcare professionals through innovative technologies and solutions.