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Senior Manager, Biostatistics

Company: Horizon Therapeutics
Location: Reston
Posted on: November 20, 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.

The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.

Responsibilities:

  • Support 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.
  • Serve as primary author for statistical sections of protocol.
  • Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)
  • Participate in development of EDC database and interactive response technology (IxRS) specifications
  • Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
  • Implement innovative statistical techniques that will provide benefit to Horizon clinical development programs
  • Contribute to strategic planning and go/no go decision guidance
  • Review biostatistics and statistical programming tasks outsourced to vendors
  • Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed
  • Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
  • 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 3 years of industry experience or MS in statistics or related field and at least 5 years of industry experience.
    • Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically.
    • Proficient in Microsoft Office
    • Professional, proactive demeanor
    • 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.
      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. Associated topics: bioinformatics, biometrics, biostatistics, data analyst, data science, sas, statistics

Keywords: Horizon Therapeutics, Reston , Senior Manager, Biostatistics, Executive , Reston, Virginia

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