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... Development of Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies. Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses. Review protocols and contribute to protocol statistical analysis sections and generate study randomization scheme when appropriate. Author results sections of the clinical study reports and supply statistical input for PMA submissions and in response to regulatory questions. Provide independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, publications, and other content delivered to external entities. Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings. Represent Biostatistics in study team and work with management and other team members regarding study status and timeline update. Participate in developing case report forms and clinical database and data cleaning to ensure quality data collection. What you'll need (Required): Ph.D. in Biostatistics, Statistics, or related; field internship, senior projects, or thesis in Statistics, Biostatistics or related field Master's Degree in Biostatistics, Statistics, or related; plus, 2 full years of previous biostatistics, analytical experience in clinical trials What else we look for (Preferred): Must be proficient with SAS; proficiency with additional software packages such as R or S-Plus desired Must have sound knowledge of theoretical and applied statistics. Must have sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting. Effective skills in communication and team collaboration. Proven expertise in SAS Experience using other software packages (e.g., R, S-Plus) 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. For California (CA), 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., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #J-18808-Ljbffr Edwards Lifesciences
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