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.
The primary role of this position is to support planned and ongoing clinical trials including sample size estimation, writing or reviewing statistical analysis plans, reviewing protocols, reviewing tables, listings and figures, and providing input into clinical study reports.
Lead, develop, and coordinate biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
Evaluate and implement innovative statistical techniques that will provide benefit to Horizon clinical development programs
Contribute to strategic planning and go/no go decision guidance
Participate in vendor selection for biostatistics, statistical programming, data management, interactive response technology (IxRS), and other services wherein data storage and analysis may be applicable; manage and oversee biostatistics and statistical programming tasks
Interact with regulatory agencies and respond to requests
Participate in or manage Biometrics participation in risk-based monitoring plans and activities
Ensure timeliness and quality of deliverables
Travel as needed to execute assigned responsibilities and tasks
Qualifications and Skills Required:
PhD in statistics or related field and at least 5 years of industry experience or MS in statistics or related field and at least 8 years of industry experience.
Proficient in Microsoft Office
Professional, proactive demeanor
Strong interpersonal skills
Excellent written and verbal communication skills
Experience with people management and development of staff
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:
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.