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Manager, Biostatistics (Remote) - Transcatheter Mitral & Tricuspid Therapies (TMTT)

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: May 3, 2021

Job Description:

Edwards Lifesciences' trailblazing Transcatheter Mitral & Tricuspid Therapies (TMTT) division is looking for a Manager, Biostatistics to be based in either the 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.

Keywords: Edwards Lifesciences Corp, Irvine , Manager, Biostatistics (Remote) - Transcatheter Mitral & Tricuspid Therapies (TMTT), Other , Irvine, California

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