Director of Biostatistics

Join us in transforming patient lives through innovative clinical evidence generation. Our Clinical Affairs team is dedicated to evaluating data and increasing access to groundbreaking technologies essential for patients in need. Collaborate closely with principal investigators, medical professionals, patient advocacy groups, and regulatory authorities to drive the necessary evidence that optimizes patient outcomes.

Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is at the forefront of addressing unmet clinical needs for patients with mitral and tricuspid heart valve disease. Become a part of this compelling journey focused on enhancing patients' quality of life.

Your impact will include...

• Leading a talented team of biostatisticians to shape clinical study designs and drive data analysis that fuels new product innovations.

• Providing strategic technical leadership across multiple complex clinical programs, fostering collaboration among cross-functional teams.

• Overseeing the biostatistics team and managing budgets effectively to maximize research impact.

• Defining statistical methodologies and real-world evidence strategies that influence research publications and ensure regulatory success.

• Acting as the lead biostatistician for assigned clinical trials, ensuring robust statistical integrity and actionable insights.

• Developing talent development plans to foster leadership within your biostatistics team.

• Driving strategic biostatistics initiatives and engaging internal and external stakeholders.

• Leading process improvement initiatives to enhance efficiency in biostatistics and related functions.

• Establishing and refining standard operating procedures (SOPs) to ensure accuracy and compliance.

• Managing high-impact activities while proactively mitigating risks and collaboratively resolving issues.

• Providing statistical expertise to key stakeholders across various teams, including marketing and health economics.

• Overseeing resource planning and analysis to ensure effective support for biostatistics functions.

• Ensuring the integrity and success of clinical trials conducted by your direct reports.

• Contributing to initiatives that shape the future of medical device development.

Requirements:

• A Ph.D. or equivalent in Statistics, Biostatistics or a related field, accompanied by significant analytical experience in clinical trials.

• Proven experience managing teams, providing coaching, feedback, and overseeing all aspects of employee relations.

Preferred Qualifications:

• Demonstrated leadership in managing teams and projects to deliver innovative and successful complex initiatives.

• Extensive experience in biostatistics, applying complex methodologies to clinical trials data.

• Deep knowledge of clinical trial design and statistical methodology, capable of solving complex challenges.

• Experience in publications and real-world evidence generation with a focus on clinical outcomes.

• Strategic understanding of biostatistics processes, enabling optimal application across multiple projects.

• Exceptional communication and negotiation skills, effectively using data-driven insights to influence decisions.

• Ability to coach, mentor, and manage team members in all aspects of employee relations.

• Strong attention to detail ensuring accuracy and compliance in statistical analyses.

• Ability to build professional relationships across all organizational levels and manage sensitive situations effectively.

• Capacity to thrive in dynamic environments and the adaptability to changing priorities.

• Active engagement with senior stakeholders to influence operational decisions and shape strategic direction.

• Proven ability in leading technical meetings and collaborative initiatives with external partners.

• Commitment to quality service, proactively addressing stakeholder needs and challenges.

• Influencing organizational change through established relationships and insights.

• Strong leadership skills, adept at reaching consensus in complex environments.

• Expertise in statistical programming using SAS and/or R for advanced clinical analysis.

• Proficient in Microsoft Office Suite 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 base pay range for this position is $205,000 to $255,000, depending on various factors such as qualifications and experience.

Edwards is an Equal Opportunity/Affirmative Action employer. We prioritize the safety of our patients and healthcare providers. Hence, all patient-facing and in-hospital roles require COVID-19 vaccination, with medical or religious accommodations available.