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Edwards Lifesciences Manager, Biostatistics (Remote, US / TMTT) in Montana

This is an exciting opportunity for an exceptional biostatistician professional with significant experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies 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 Biostatistics Manager, 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.

Essential Job Functions / Key Responsibilities

  • 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 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 Requirements

  • Ph.D. in Statistics or Biostatistics with 4 years of previous analytical experience in clinical trials OR

  • Master's degree in Statistics or Biostatistics with 7 years of previous analytical experience in clinical trials OR

  • Bachelor's degree in Statistics or Biostatistics with 8 years of previous analytical experience in clinical trials

  • Proficiency in a statistical programming language such as SAS and R

  • Proven successful project management leadership skills

  • Proven track of successful experience in NDA/IDE/PMA/PMDA/CE mark submissions

  • Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems

  • Capable of independently leading pivotal trials

  • Experience using PASS or EAST

  • Experience in trial simulations for sample size and power calculation

  • DMC/DSMB experience

  • Familiar with survival, regression and categorical data analysis methods

Preferred Qualifications:

  • Medical Device experience

  • Adaptive design experience

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 $149,000 to $173,000.

Additional information can be found through the link below:

Edwards 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.