Manager - Biostatistics

Company: Horizon Therapeutics
Location: Bethesda
Posted on: March 17, 2023

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. 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 tasksQualifications 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 resultsOur Values
    • Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
    • Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
    • Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employees
      • Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
      • Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
      • Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
      • Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
      • Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleAt Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Bethesda , Manager - Biostatistics, Executive , Bethesda, Maryland