Senior Principal Biostatistician (Epidemiology)

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.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.The Senior Principal Biostatistician (Epidemiology) will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind.How you will make an impact:Lead end-to-end evidence strategies, designing observational studies, interventional trials, and real-world evidence (RWE) programs to support pipeline and on-market productsBuild economic models (cost-effectiveness, budget impact) to clearly communicate the clinical, and economic value of Edwards productsStatistical lead on multiple clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analysesCollaborate with cross-functional partners and external analysts in the execution of studies and implementation of field-based, customer-focused initiatives and partnerships (e.g., models, presentations, publications, formulary/regulatory dossiers).Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline updateProvide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project teamResearch and recommend novel statistical methodology and/or approachesContribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs)Lead the efforts of data analysis for data monitoring committee as neededMentor junior statisticians and work with management in resource allocation and budget/timeline development activitiesWhat you'll need (Required):Bachelor's Degree in Statistics, Biostatistics, or related field, 8 years of previous analytical experience in clinical trials orMaster's Degree or equivalent in Statistics, Biostatistics, or related field, 7 years of previous analytical experience in clinical trials orPh.D. or equivalent in Statistics, Biostatistics, or related field , 4 years of experience What else we look for (Preferred):Medical device industry experience strongly preferred, including statistical support for clinical studies, real-world evidence, and regulatory submissions.Deep knowledge of outcomes research and RWE methodologies (study design, statistics, data sources, and implementation)Deep knowledge of observational study methods, causal inference, economic model (cost-effectiveness), epidemiologyProven experience managing vendors, budgets, and building productive partnerships with internal stakeholders and external experts/KOLsDemonstrated leadership in matrixed environments, including the ability to direct work across functions to deliver shared objectivesProven expertise in SAS required; experience using other software packages (e.g., R, S-Plus) preferred Proven expertise in MS Office Suite including Word, PowerPoint, Access, and ExcelExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesKeeps abreast of new developments in statistics and regulatory guidanceExpert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analysesExpert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research settingExcellent problem-solving, organizational, analytical and critical thinking skillsStrong leadership skills and ability to influence changeAbility to provide training and coaching to lower level employeesExperience in facilitating change, including collaboration with management and executive stakeholdersAligning 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, the base pay range for this position is $151,000 - $215,000 (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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.SummaryLocation: USA - California – Irvine; #LI-REMOTEType: Full time