Biostatistics Director

Join us in revolutionizing patient outcomes through state-of-the-art clinical evidence generation. Our Clinical Affairs team is focused on analyzing data and expanding access to transformative technologies that are crucial for patients. Collaborate with principal investigators, medical professionals, patient advocacy groups, and regulatory authorities to produce the vital evidence that enhances patient care. Become a vital part of our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit, committed to addressing significant unmet clinical needs for patients with mitral and tricuspid heart valve diseases. This is a compelling journey dedicated to boosting the quality of life for patients. Your contributions will encompass... Leading an accomplished team of biostatisticians to design clinical studies and perform data analysis that drives innovative product development. Providing strategic leadership and guidance across multiple intricate clinical programs while encouraging collaboration among diverse teams. Overseeing the biostatistics team and managing budgets effectively to amplify research outcomes. Establishing statistical methodologies and real-world evidence strategies that support research publications and regulatory success. Acting as the lead biostatistician for specific clinical trials, ensuring the integrity of statistical analysis and deriving actionable insights. Creating talent development plans to nurture leadership within your biostatistics team. Pursuing strategic biostatistics initiatives and engaging with internal and external stakeholders. Leading process improvement initiatives that enhance efficiency within biostatistics and related functions. Formulating and refining standard operating procedures (SOPs) to ensure accuracy and compliance. Managing high-impact activities while proactively addressing risks and collaboratively resolving issues. Providing statistical expertise to key stakeholders across diverse teams, including marketing and health economics. Overseeing resource allocation and analysis to ensure robust support for biostatistics functions. Guaranteeing the integrity and success of clinical trials conducted by your team members. Contributing to initiatives that shape the future of medical device innovation. Qualifications: Ph.D. or equivalent in Statistics, Biostatistics, or a related discipline, along with substantial analytical experience in clinical trials. Demonstrated experience in team management, providing guidance, feedback, and overseeing all areas of employee relations. Preferred Skills: Proven leadership in managing teams and projects to deliver innovative, successful, and complex initiatives. Extensive expertise in biostatistics with experience in applying advanced methodologies to clinical trial data. Comprehensive knowledge of clinical trial design and statistical methodologies, capable of tackling complex challenges. Experience in publications and real-world evidence generation with a focus on clinical outcomes. Strategic understanding of biostatistics processes, optimizing application across multiple projects. Exceptional communication and negotiation abilities, skillfully using data-driven insights to influence decisions. Capability to coach, mentor, and manage team members effectively in all areas of employee relations. Strong attention to detail, ensuring precision and compliance in statistical analyses. Adept at building professional relationships across all organizational levels and managing sensitive situations effectively. Ability to thrive in fast-paced environments while adapting to evolving priorities. Active engagement with senior stakeholders to influence operational decisions and shape strategic direction. Demonstrated proficiency in leading technical meetings and collaborative initiatives with external partners. Commitment to quality service, proactively addressing stakeholder needs and challenges. Capacity to influence organizational change through established relationships and insights. Strong leadership capabilities, well-versed in achieving consensus in complex settings. Expertise in statistical programming using SAS and/or R for advanced clinical analysis. Proficient in Microsoft Office Suite, vital for analytical and reporting functions. We offer competitive salaries, performance-based incentives, and a comprehensive benefits program tailored to meet the diverse needs of our employees and their families. The salary range for this role is $205,000 to $255,000, influenced by qualifications and experience. Edwards is an Equal Opportunity/Affirmative Action employer. We prioritize the safety of our patients and healthcare providers; therefore, all patient-facing and in-hospital roles require COVID-19 vaccination, with medical or religious accommodations available.

Created: 2026-03-11