Job Description

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...** + Strategically planning and executing statistical tasks for assigned studies, ensuring rigorous methodology and scientific integrity under the guidance of senior statisticians. + Designing and leading the development of Statistical Analysis Plans (SAPs), driving high-quality execution and insightful data interpretation. + Developing statistical programs to verify and enhance the accuracy of planned analyses, exploratory investigations, and critical study results. + Providing expert review of study protocols, contributing to statistical analysis sections, and generating robust randomization schemes where applicable. + Conducting data analysis to support the development of clinical study report, clinical evaluation report, conference or journal publications, and other regulatory submission as needed + Work closely with cross-functional teams to assist development of manuscript, abstract/presentation, and provide statistical support throughout the publication process + Independently validating statistical content across study documents-including randomization schemes, study reports, briefing materials, patient brochures, visualizations and publications-ensuring precision and compliance in external communications. + Staying at the forefront of statistical innovation, medical device development trends, and regulatory advancements through ongoing literature review and professional engagements. + Serving as the Biostatistics representative in study teams, collaborating with management and cross-functional colleagues to ensure alignment on study status and timelines. + Contributing to the development of case report forms and clinical databases while overseeing data cleaning processes to maintain the highest standards of data quality. **What you'll need (Required):** + Ph.D. in Biostatistics, Applied Statistics, Data Science, or a related field, with hands-on experience through a field internship or thesis in applied statistical methods, data science, or real-world problem-solving in medical research. + Master's degree in Biostatistics, Applied Statistics, Data Science, or a related field, complemented by practical experience in applied methodologies through a field internship, or thesis focusing on data science or medical research applications. **What else we look for (Preferred):** + Extensive publication record, demonstrating a strong ability to apply statistical methods effectively in medical and research settings. + Strong problem-solving, organizational, analytical and critical thinking skills, with the ability to work independently or collaboratively in multidisciplinary research environments. + Proficiency in SAS, with additional experience in other statistical software packages such as R or S-Plus preferred, ensuring versatility in data analysis. + Solid understanding of applied statistics/data mining/machine learning, with a sound knowledge of theoretical concepts but a primary focus on practical implementation. + Familiarity with regulatory guidelines (e.g., GCP, FDA) relevant to pharmaceutical and medical device research. + Strong communication and collaboration skills, ensuring effective teamwork in cross-functional environments. + Adherence to company policies and safety protocols, including pandemic guidelines and environmental protection measures. 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. The base pay range for this position is $116,000 to $164,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. 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.

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