Director, Biostatistics

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

You will make an impact by...

• Lead a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation

• Provide technical and strategic leadership for multiple complex clinical programs in collaboration with cross-functional teams

• Manage and oversee the biostatistics team, including financial budget responsibilities to optimize research efforts

• Define statistical methodologies and real-world evidence strategies, influencing research publication and regulatory success

• Act as core team member/lead biostatistician for assigned clinical trials, ensuring statistical integrity and impact

• Develop and implement talent development plans, fostering growth and leadership within the biostatistics team

• Guide broad, complex biostatistics strategies, including negotiations with internal and external stakeholders

• Drive process improvement initiatives, enhancing efficiency across biostatistics and cross-functional areas

• Create and implement SOPs, processes, and standards, ensuring compliance, accuracy, and optimization

• Plan and manage high-impact activities, mitigating risks and resolving issues in collaboration with cross-functional teams

• Provide statistical expertise to internal and external stakeholders, including marketing, health economics, and reimbursement teams

• Oversee resource analysis and planning to ensure optimal support for biostatistics functions

• Accountable for clinical trials assigned to direct reports, ensuring study integrity and success

• Other incidental duties, contributing to additional initiatives shaping the success of medical device development

What you'll need (Required):

• Ph.D. or Master’s degree (or equivalent) in Statistics, Biostatistics, or a related field

• Extensive biostatistical experience applying complex methodologies and analyzing clinical trials data

• Extensive experience on publications and real-world evidence generation

• Proven leadership managing a team of direct reports, driving innovation and excellence in biostatistics

Preferred Qualifications:

• Deep expertise in clinical trial design, applying advanced methodologies to solve complex challenges

• Extensive experience in statistical methodology, publications, and real-world evidence generation

• Strategic understanding of biostatistics processes and systems, ensuring optimal application across projects

• Proven leadership in project management, delivering successful outcomes across complex initiatives

• Exceptional communication and negotiation skills, leveraging data-driven insights to influence decisions and achieve optimal business outcomes.

• Demonstrated ability to lead and manage teams, providing coaching, feedback, and partnering on all aspects of employee relations; Support and engage team members at all levels, fostering growth, teamwork, innovation and shared success

• Meticulous attention to detail, ensuring precision and compliance in statistical analyses and reporting

• Professional presence across all organizational levels, with the ability to escalate issues proactively

• Thrives in a fast-paced, dynamic environment, adapting to evolving priorities and business needs

• Frequent interactions with senior stakeholders, influencing operational decisions and strategic direction

• Lead technical meetings and briefings, engaging both internal and external representatives

• Develop