Sr Manager, Biostatistics

Company: Horizon Therapeutics
Location: Silver Spring
Posted on: June 17, 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 provide statistical support for medical affairs and outcomes research. Apply statistical principles and techniques to a wide range of problems in clinical development and life-cycle management with the supervision of more senior staff.

Responsibilities:

• Support biostatistical activities for Medical Affairs and Outcomes Research, and Clinical Development.
• Provide statistical support for manuscripts, abstract submissions, presentations, and posters at medical meetings and any other requests not covered in the clinical study report.
• Contribute to planning and execution of exploratory analyses of clinical trial data, investigator initiated trials and relevant external and internally generated real-world data to support strategic business objectives.
• Interact with authors, referees and in-house reviewers in the preparation of manuscripts, abstracts, presentations and posters.
• Provide statistical input for design, sample size and protocol for Medical Affairs studies.
• Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells, data tables and figures to source findings) for Medical Affairs or Ad/Post Hoc analyses of R&D studies and other trial results
• Collaborate with medical affairs, project management, regulatory, PV/safety, business development, and commercial functions to develop successful analysis plans
• Implement innovative statistical and presentation formats and techniques that will provide benefit to Horizon clinical development programs
• Perform statistical analyses and SAS programming validation if needed
• Ensure timeliness and quality of deliverables
• Travel as needed to execute assigned responsibilities and tasks
• Work with Medical Affairs and Corporate Analytic teams' data scientists to develop the most robust analyses possible for projects undertaken
  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.
  • Able to analyze clinical trial, quality of life and real-world data.
  • Proficient SAS programming skills and experience with other statistical software packages (R, Python, etc). Ability to contribute strategically.
  • Prefer experience in working with and analyzing big real world data sets (IQVIA, Symphony, others)
  • 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 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, Silver Spring , Sr Manager, Biostatistics, Executive , Silver Spring, Maryland