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Senior Manager Statistical Programming (Remote USA) TMTT

Company: Edwards Lifesciences
Location: Irvine
Posted on: August 3, 2022

Job Description:

This is an outstanding and unique opportunity for a Senior Manager, Statistical Programming to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies! TMTT is passionate about developing solutions for patients suffering from structural heart disease. This is a fast-paced dynamic, and diverse team and the individual in this position will play a pivotal role in the development of new therapies and devices, from concept through to human use.You will manage a team and oversee statistical programming activities for clinical trials in SAS. You will take primary role in developing analysis datasets in multiple clinical trials and review and validation of SAS programs created by the programmers.Key Responsibilities including but not limited to:

  • Manage and oversee the work of a small team of statistical programmers and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
  • Provide programming expertise on multiple clinical trials for analysis for inclusion in clinical study reports, presentations, or select publications in collaboration with project statistician
  • Provide programming expertise on complex ad hoc data requests in collaboration with project statistician
  • Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties
  • Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
  • Lead a team of programmers in collaboration with cross-functional teams to ensure that database and external data source when applicable meet analysis requirements across clinical trials
  • Develop and revise statistical programming procedures or instructionsRequired Qualifications:
    • Bachelor's Degree in STEM and a minimum of 8 years' experience in statistical analysis OR Master's degree requires 5 years' experience OR PhD requires 2 years' experience
    • Experience working in clinical trials and preparing study submissions
    • Previous people leader experience
    • Proven successful project management leadership skills
    • Expertise in SAS and Windows operating systems
    • Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research settin
    • Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
    • Currently live within the US with ability to travel at least once per quarter to global HQ (Irvine, CA) for trainingPreferred Qualifications:
      • Keeps a strong pulse on new developments in statistics and regulatory guidance
      • Experience using other software packages (e.g., R, S-Plus)
      • Excellent problem-solving, interpersonal, analytical and critical thinking skill
      • Strong leadership skills and ability to inspire change
      • Ability to provide training and mentorship to lower-level employees
      • Experience in facilitating change, including collaboration with management and executive stakeholders
      • Strict attention to detail
      • Ability to lead opposing priorities in a fast-paced environment
      • Ability to work in a team environment, including serving as consultant to management
      • Experience in interacting with suppliers, vendors and/or customersFor 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 through the link below:

Keywords: Edwards Lifesciences, Irvine , Senior Manager Statistical Programming (Remote USA) TMTT, Executive , Irvine, California

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