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Manager, Statistical Programming

Company: Horizon Therapeutics
Location: San Leandro
Posted on: September 19, 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:

Working with the Biometrics staff, the candidate will provide programming support for Phase 1 to Phase 4 studies. The candidate will provide timely support to the project team on all statistical programming matters according to the project strategy, program SDTM, ADaM datasets, tables, figures and listings (TFLs) for the studies, write dataset specifications, provide quality control for datasets, tables, figures and listings, maintain records and timelines, identify and communicate changes in project requirements that may affect key deliverables.

Responsibilities

The primary role of this position is to assist or lead the statistical programming function that supports planned and ongoing clinical trials. Specifically, the Manager, statistical programming will be expected to:

  • Involve in the programming activities on multiple projects/studies across various therapeutic areas, both internally and externally by CROs.
  • Assist or lead multiple studies for Phase 1 to Phase 4.
  • Create and review annotated CRF to SDTM datasets.
  • Provide support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives.
  • Function as a positive role model for setting high expectations for quality, creativity and project ownership.
  • Works collaboratively with Clinical Operation, Statistics, Data Management, Global Drug Safety, Medical Affair, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
  • Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers).
  • Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
  • Involve with the strategy for process improvement.
  • Identify new tools to increase efficiency and quality and assist with implementing.

    Required Qualifications, Skills and Education:
    • Master's Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related discipline.
    • Minimum of 2-7 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
    • Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus.
    • Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies.
    • Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programming projects.
    • Excellent organizational skills and ability to prioritize tasks.
    • Excellent communication and interpersonal skills.
      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 requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). 'Fully vaccinated' is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.

            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.by Jobble

Keywords: Horizon Therapeutics, San Leandro , Manager, Statistical Programming, Executive , San Leandro, California

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