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Senior Manager/Associate Director, Biostatistics

Company: Horizon Therapeutics
Location: Silver Spring
Posted on: May 14, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

The primary role of this position is to function independently as a lead statistician for one or more clinical development programs to provide statistical expertise and strategic input across all phases of clinical development with minimal supervision.

Responsibilities:

  • Lead, develop, and coordinate biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
  • Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
  • Effectively collaborate and influence throughout multiple levels of the organization.
  • Evaluate and implement innovative statistical techniques that will provide benefit to Horizon clinical development programs
  • Contribute to strategic planning and go/no go decision guidance
  • Responsible for statistical aspects of internal governance reviews
  • Participate in vendor selection for biostatistics, statistical programming, data management, interactive response technology (IxRS), and other services wherein data storage and analysis may be applicable
  • Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables
  • Be responsible for the statistical designs of clinical trial and create statistical sections for study protocols
  • Authoring or overseeing authorship of statistical documents (eg. statistical analysis plan and statistical programming plan)
  • Participate in development of EDC database and development of IxRS specifications
  • Lead Biostatistics activities for the regulatory submission documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
  • Provide statistical input/contributions to regulatory submissions and interactions, response to questions from the FDA and Advisory Committee meetings if needed
  • Participate in or manage Biometrics participation in risk-based monitoring plans and activities
  • Ensure timeliness and quality of deliverables
  • Travel as needed to execute assigned responsibilities and tasks

    Qualifications and Skills Required:
    • PhD in statistics or related field and at least 5 years of industry experience or MS in statistics or related field and at least 8 years of industry experience.
    • Experience as an independent lead statistician with responsibility for multiple studies or projects
    • Experience in regulatory interactions and submissions
    • Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically.
    • Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.
    • Proficient in Microsoft Office
    • Excellent written and verbal communication skills
    • Experience with people management and development of staff
    • Excellent interpersonal and project management skills
    • Able to collaborate effectively with internal and external study management teams to meet project timelines
    • Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results
    • Requires juggling multiple projects with varying priorities. Requires ability to recognize issues that may critically affect statistical analyses and to relay that information to appropriate level of management

      Horizon Core Values & Competencies:

      Growth
      • Manages Ambiguity
      • Strategic Mindset
      • Demonstrates Self-awareness
      • Cultivates Innovation
      • Develops Talent

        Accountability
        • Drives Results
        • Ensures Accountability
        • Decision Quality

          Transparency
          • Courage
          • Collaboration
          • Instills Trust

            Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Silver Spring , Senior Manager/Associate Director, Biostatistics, Executive , Silver Spring, Maryland

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