Manager - Biostatistics - Now Hiring

Company: Horizon Therapeutics
Location: Rockville
Posted on: January 19, 2023

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 provide statistical support across all phases of clinical development and apply statistical principles and techniques to a wide range of problems within the clinical development environment with supervision of senior Biostatistics staff.

Responsibilities:

• Function as independent project statistician for multiple clinical studies
• Represent Biostatistics in project team meetings and other project activities
• Serve as primary author for statistical sections of protocol and create accompanying statistical documents (eg. statistical analysis plan and mock tables, listings, and figures (TLFs) shells)
• Participate in development of interactive response technology (IRT) specifications and EDC database
• Perform SAS programming validation, and statistical analyses for clinical publications and other communications if needed
• Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
• Collaborate with clinical development, project management, regulatory affairs, medical affairs, Patient Safety and Pharmacovigilance (PSPV), business development, and commercial functions
• Implement innovative statistical techniques that will provide benefit to Horizon clinical development programs
• Review and manage biostatistics and statistical programming tasks outsourced to vendors
• Ensure timeliness and quality of deliverables
• Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLAs/NDAs if needed
• Travel as needed to execute assigned responsibilities and tasks
  
  Qualifications and Skills Required:
  
  • PhD in statistics or related field and at least 1 year of industry experience or MS in statistics or related field and at least 3 years of industry experience.
  • Proficient in Microsoft Office.
  • Professional, proactive demeanor.
  • Strong interpersonal skills
  • Excellent written and verbal communication skills
  • Excellent interpersonal and project management skills
  • Comprehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and statistical software packages. Experience with interventional, observational and retrospective studies. Ability to contribute strategically.
  • 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.

Keywords: Horizon Therapeutics, Rockville , Manager - Biostatistics - Now Hiring, Executive , Rockville, Maryland