Job Description

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 Principal Biostatistician will apply advanced biostatistical expertise to support clinical research and inform strategic decision-making through hands-on statistical analysis of clinical data. Serve as a technical contributor with direct responsibility for implementing statistical methodologies, interpreting results, and delivering high-quality analyses in a highly data-driven environment.How you will make an impact:Statistical 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 core stakeholders to provide statistical expertise in support of multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as neededRepresent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline updateResearch and recommend novel statistical methodology and/or approachesProvide statistical expertise and guidance to internal and external stakeholders on ad hoc data analysis requests and publication/presentation efforts related to the project teamCompile technical documents for internal and external auditsContribute 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):Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years’ experience of experienceMaster's Degree or equivalent in Statistics, Biostatistics, or related field, 5 years’ experience of previous analytical experience in clinical trials Required ORWhat else we look for (Preferred):Proven expertise in R; experience with additional statistical software packages (e.g., S-PLUS or other analytics tools)Experience with CDISC standards (e.g., SDTM and ADaM), demonstrating expertise in clinical trial data structures, data standardization, and regulatory-compliant statistical analysisValidate statistical outputs and review Tables, Listings, and Figures (TLFs); develop TLF shells and contribute to the preparation of study-related documentationProven 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 DeviceExcellent 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.The base pay range for this position is $132,000 to $186,000 (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.SummaryLocation: USA - California – Irvine; #LI-REMOTEType: Full time

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