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...** + Represent the Biostatistics department throughout all aspects of the clinical development process, ranging from trial design to regulatory submissions, while applying scientific rigor to statistical methods and interpretation of results. + Advice on the conduct of clinical studies, database development, and data quality assurance with the analysis of clinical endpoints in mind. + Leading as the statistical authority on multiple, complex clinical trials; driving analyses for study reports and related documents and ensuring robust programming and validation while advising on advanced statistical methodologies. + Partnering with cross-functional teams to deliver strategic statistical expertise for new product development (NPD) and regulatory submissions (e.g., PMA, CE Mark, PMDA), influencing critical regulatory decisions. + Representing Biostatistics on project and study teams; proactively communicating project status, timelines, and deliverables to management and stakeholders. + Leading integration by developing and implementing novel statistical methodologies and approaches that enhance trial design and data interpretation. + Driving global process improvements in Biostatistics, including standardization initiatives and SOP development, to strengthen operational excellence. + Providing expert statistical guidance for ad hoc analyses, publications, and presentations that support scientific and business objectives. + Mentoring junior statisticians and collaborating with management on resource allocation, budgeting, and strategic timeline planning. + Authoring technical documentation to ensure compliance and readiness for internal and external audits. **What you'll need (Required):** + Master's in Statistics, Biostatistics, or a related field with 11 years of biostatistical research and analytical experience in clinical trials + Ph.D. in Statistics, Biostatistics, or a related field with 8 years of biostatistical research and analytical experience in clinical trials **What else we look for (Preferred):** + Lead the integration of Real-World Evidence (RWE) and advanced AI-driven analytical methods into new product development metrics for cutting-edge heart valve technologies. + Demonstrated expertise in statistical methodologies for clinical trial design, modeling, and data analysis, with proficiency in SAS and/or R. + Strategic insight into biostatistics processes and systems, enabling effective application across diverse and complex projects. + Proven leadership in project management, mentoring, and driving organizational change, with a track record of delivering complex initiatives efficiently and influencing outcomes. + Advanced proficiency in MS Office Suite (Word, PowerPoint, Access, Excel). + Exceptional communication skills, both written and verbal; adept at stakeholder engagement, negotiation, and cross-functional collaboration. + Comprehensive knowledge of regulatory guidelines (GCP, ICH, FDA, ISO) in pharmaceutical and medical device research. + Strong analytical and problem-solving abilities, with critical thinking skills and meticulous attention to detail. + Ability to manage competing priorities in fast-paced environments while maintaining high-quality standards. + Comfortable engaging across all organizational levels and leading meetings with internal and external stakeholders. + Commitment to Environmental Health & Safety and adherence to company policies and compliance protocols. + Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control + 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 $205,000 to $255,000 (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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