Associate Director, Statistical Programming

Company: Horizon Therapeutics
Location: San Mateo
Posted on: May 13, 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:

Responsible for the development and maintenance of statistical programming functions to support various projects. Manages programmers and CROs, oversees programming activities related to certain clinical programs and studies. Help with the development of the programming strategy works in the development of the SAS programming infrastructure and coordinates the effort across therapeutic areas to identify, develop and implement departmental standards, applications, and processes. Provides timely support to the project teams on statistical programming matters according to the project strategies and is responsible for addressing all administrative functions required for project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level.

Responsibilities

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

• Help to build the statistical programming function, such as developing processes, developing relationships with key stakeholders, recruiting programmers, enforcing standards as the associate director.
• Responsible for the development, review, validation, and execution of SAS programs to generate Tables, Figures, and Listings.
• Create and review annotated CRF and SDTM datasets.
• Translate the SAP into programming specifications for analysis datasets (ADaM).
• Review key study-related documents produced by other functions, such as case report forms.
• Review the DMP, SAP, and TFL specifications, and provide feedback to the statisticians and data managers.
• Develop, review, validate, and execute SAS programs to generate standard (SDTM and ADaM) and non-standard (custom study-specific) datasets to be included in reports for submission to regulatory agencies, publications, and other communications.
• Assist with SAS Programming Infrastructure including the design, creation, and validation of global SAS macros and utilities that streamline operations to increase programming efficiency. Support the development of statistical programming processes to ensure the best quality statistical outputs.
• Manage the programming activities on multiple projects and studies across various therapeutic areas, programmed either internally or externally by CROs.
• 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.
• Work collaboratively with Clinical Operation, Data Management, Statistics, Global Drug Safety, Medical Affairs, 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 functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
• Assist in setting the strategy for process improvement.
• Identify new tools to increase efficiency and quality and assist with implementation.
  Required Qualifications, Skills, and Education:
  
  • Master's Degree in Statistics, Biostatistics, Mathematics, Epidemiology, or related discipline.
  • Minimum of 7-12 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.
  • Experience in developing SAS macros to standardize the workflow and internal processes.
  • Self-directed, technically strong, and a recognized leader maintaining a strategic perspective 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.

Keywords: Horizon Therapeutics, San Mateo , Associate Director, Statistical Programming, Executive , San Mateo, California