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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.The Staff Biostatistician 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 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 analyses
Collaborate 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 needed
Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team
Compile technical documents for internal and external audits
Contribute 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 collection
Lead the efforts of data analysis for data monitoring committee as needed
Minimum RequirementsPhD in Statistics, Biostatistics or related field with 2 years of previous analytical experience in clinical trials OR
Master's degree in Statistics, Biostatistics or related field with 5 years of previous analytical experience in clinical trials OR
Bachelor's degree in Statistics, Biostatistics or related field with 6 years of previous analytical experience in clinical trials
Must be proficient with SAS and/or R
Knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
Knowledge and understanding of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical or Medical Device research setting
Preferred QualificationsKnowledge in adaptive design (e.g. sample size re-estimation, group sequential design, Bayesian adaptive design)
Bayesian analysis
Analysis using historical control
Experience with PMA submissions
Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel
Experience 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 $129,000.00 to $151,000.00Additional information can be found through the link below:https://www.edwards.com/careers/benefitsEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards 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 or have a valid religious or medical exemption from being vaccinated.Edwards 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 15,000 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.
