Sr Manager, Biostatistics

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 provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.Responsibilities:Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business DevelopmentProvide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs.Serve as primary author for statistical sections of protocol.Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)Participate in development of EDC database and interactive response technology (IxRS) specificationsCollaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functionsImplement innovative statistical techniques that will provide benefit to Horizon clinical development programsContribute to strategic planning and go/no go decision guidanceReview biostatistics and statistical programming tasks outsourced to vendorsPerform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if neededSupport the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if neededEnsure timeliness and quality of deliverablesTravel as needed to execute assigned responsibilities and tasksQualifications 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 prehensive knowledge of clinical trials methodology (experience with Bayesian methods preferred), regulatory requirements, and proficient SAS programming skills and experience with other statistical software packages. Ability to contribute strategically.Proficient in Microsoft OfficeProfessional, proactive demeanorExcellent written and verbal communication skillsExperience with people management and development of staffExcellent interpersonal and project management skillsAble to collaborate effectively with internal and external study management teams to meet project timelinesMust 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.

Created: 2025-11-15