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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 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.As a Senior Manager, Biostatistics , you 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. You are also responsible for a team of biostatisticians and activities while ensuring proper design, analysis and presentation of clinical studies.Key ResponsibilitiesStatistical lead on multiple 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 multiple new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed
Represent Biostatistics on multiple project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update
Research and recommend novel statistical methodology and/or approaches
Provide statistical expertise and guidance to internal and external stakeholders 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)
Lead the efforts of data analysis for data monitoring committee as needed
Mentor junior statisticians and work with management in resource allocation and budget/timeline development activities
Minimum QualificationsPhD in Statistics or Biostatistics with 4 years of previous analytical experience in clinical trials or clinical research OR
Master's degree in Statistics or Biostatistics with 7 years of previous analytical experience in clinical trials or clinical research OR
Bachelor's degree in Statistics or Biostatistics with 8 years of previous analytical experience in clinical trials or clinical research
Must be proficient with SAS and/or R
Experience utilizing R to perform simulations and generate graphics (such as ggplot)
Preferred QualificationsKnowledge in adaptive design (e.g. sample size re-estimation, group sequential design, Bayesian adaptive design)
Bayesian analysis
Analysis using historical control or RWD (e.g., registry, medical healthcare records, or claims data)
Experience with Python or other programming languages
Participated in medical publications
Demonstrated ability to manage assigned team and providing coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
General ExpectationsExpert understanding and knowledge in statistical methods related to clinical trial designs, statistical modeling and data analyses
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 $151,000 to $177,000. Additional information can be found at: 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.
