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Principal Biostatistician (PhD / SAS / R / Remote USA)

Company: Edwards Lifesciences
Location: Irvine
Posted on: September 24, 2022

Job Description:

This is an exciting opportunity for an exceptional Biostatistician professional with the experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies (TMTT) from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives.As a Principal Biostatistician, you represent the TMTT 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 advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind.The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Do not miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.Key ResponsibilitiesStatistical lead on one or more 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 new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as neededRepresent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline updateProvide statistical expertise 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)Collaborate on developing case report forms and clinical database to ensure quality data collectionLead the efforts of data analysis for data monitoring committee as neededMinimum RequirementsPhD in Biostatistics, Statistics or related field with 2 years of previous analytical experience in clinical trials ORMaster's degree in Biostatistics, Statistics or related field with 5 years of previous analytical experience in clinical trials ORBachelor's degree in Biostatistics, Statistics or related field with 6 years of previous analytical experience in clinical trialsMust be proficient with SAS and/or RKnowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analysesKnowledge and understanding of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical or Medical Device research settingPreferred QualificationsKnowledge in adaptive design (e.g. sample size re-estimation, group sequential design, Bayesian adaptive design)Bayesian analysisAnalysis using historical controlExperience with PMA submissionsProven expertise in MS Office Suite including Word, PowerPoint, Access, and ExcelExperience using other software packages (e.g., R, S-Plus)For Colorado Residents Only - 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 $129,000 to $151,000. Additional information can be found at .About Edwards LifesciencesEdwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.For United States Applicants Only:Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.EEO is the Law click here for more information regarding Equal Employment OpportunityDisability accommodation for employment applicantsEdwards E-VerifyFamily and Medical Leave Act (FMLA)Employee Polygraph Protection Act (EPPA)Pay Transparency Notice

Keywords: Edwards Lifesciences, Irvine , Principal Biostatistician (PhD / SAS / R / Remote USA), Other , Irvine, California

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