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Edwards Lifesciences Manager, Biostatistics (Remote) - Transcatheter Mitral & Tricuspid Therapies (TMTT) in New York City, United States

Edwards Lifesciences' trailblazing Transcatheter Mitral & Tricuspid Therapies (TMTT) division is looking for a Manager, Biostatistics to join the team in Irvine, CA area or remotely within the United States.

As a Manager, Biostatistics, you are responsible for a team of biostatisticians while ensuring the proper design, analysis and presentation of clinical studies.

Essential Job Functions/Key Responsibilities:

  • Act as core team member and lead biostatistician of assigned clinical trials

  • Accountable for clinical trials assigned to direct reports

  • Manage and oversee the work of biostatistics team and may indirectly manage cross functional or matrix teams

  • Provide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teams

  • Provide statistical insight/strategies to study design for complex clinical studies

  • Develop a robust talent development plan in alignment with functional growth strategies of the department

  • Develop and lead the implementation of biostatistics strategies which may include negotiations with internal and external parties

  • Provide guidance on process improvement projects within biostatistics and cross-functional areas

  • Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency and optimization

  • Manage activities with accountability for successful completion of all deliverables

  • Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams

  • Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement)

  • Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities

Minimum Requirements

  • Master's Degree in Statistics or Biostatistics with 7 years of previous analytical experience in clinical trials or Ph.D. in Statistics or Biostatistics with 4 years of previous analytical experience in clinical trials

  • Must be proficient with SAS or 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

  • Expert understanding of related aspects of biostatistics processes or systems

  • Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

  • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting

  • 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

  • Bayesian analysis

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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.