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...** + Leading a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation + Providing technical and strategic leadership for multiple complex clinical programs, collaborating with cross-functional teams + Overseeing the biostatistics team, managing budgets to maximize research impact + Defining statistical methodologies and real-world evidence strategies, influencing research publications and regulatory success + Acting as the lead biostatistician for assigned clinical trials, ensuring statistical integrity and meaningful insights + Developing and implementing talent development plans, fostering leadership within the biostatistics team + Driving complex biostatistics strategies, engaging with both internal and external stakeholders + Spearheading process improvement initiatives to enhance efficiency across biostatistics and cross-functional areas + Establishing and optimizing SOPs, processes, and standards to ensure accuracy and compliance + Managing high-impact activities, proactively addressing risks and resolving issues collaboratively + Providing statistical expertise to key stakeholders, including marketing, health economics, and reimbursement teams + Overseeing resource analysis and planning, ensuring optimal support for biostatistics functions + Ensuring clinical trial integrity and success for direct reports and assigned studies + Contributing to additional initiatives that shape the future of medical device development **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or a related + 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 **What else we look for (Preferred):** + Deep expertise in clinical trial design, applying advanced methodologies to solve complex challenges and drive innovation. + Extensive experience in statistical methodology, research publications, and real-world evidence generation, ensuring meaningful impact in clinical outcomes. + strategic understanding of biostatistics processes and systems, enabling optimal application across multiple projects and initiatives. + Strong leadership in project management, successfully delivering complex initiatives with precision and efficiency. + Exceptional communication and negotiation skills, leveraging data-driven insights to influence decision-making for optimal business results. + Proven ability to lead and manage teams effectively, providing coaching, feedback, and support across all aspects of employee relations. + Meticulous attention to detail is crucial, ensuring accuracy, compliance, and integrity in all statistical analyses and reporting. + Candidates should exhibit professional presence across all organizational levels, proactively addressing and escalating issues as needed. + Success in this role requires thriving in a fast-paced, dynamic environment, adapting to evolving priorities and business needs. + Regular engagement with senior stakeholders will be expected, shaping operational decisions and influencing strategic direction. + You will lead technical meetings and briefings, collaborating with internal and external representatives to drive initiatives forward. + Building strong relationships and cross-functional partnerships is essential, enhancing collaboration and establishing best practices while strategically advancing global enterprise system implementations. + A commitment to quality client service is paramount, responding proactively to stakeholder needs and challenges. + Candidates will play a key role in influencing organizational change, leveraging strong relationships and data-driven insights to drive transformation. + We value individuals with strong change leadership skills, capable of driving consensus in complex or sensitive situations. + Expertise in statistical programming (SAS and/or R) is highly desirable, enabling advanced clinical analyses and impactful research. + Strong proficiency in Microsoft Office Suite is essential to support analytical and reporting functions. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $205,000 to $255,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. \#LI-Remote Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.