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Manager, Biostatistics

Horizon Therapeutics
United States, Maryland, Rockville
May 29, 2023
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: Working at Horizon Therapeutics is more than a job - it's personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. 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 patients live up to theirs. Location: All locations Job Title: Manager, Biostatistics Reports To: Director, Biostatistics Function: Development Sciences Job Type: Regular/Full-Time Position Summary The primary role of this position is to support planned and ongoing clinical trials, including sample size estimation, writing or reviewing statistical analysis plans (SAPs), reviewing protocols, reviewing tables, listings and figures, and providing input into clinical study reports under supervision of the lead project Statistician. Responsibilities Support biostatistical activities for Clinical Development, Clinical Operations, and Medical Affairs Provide statistical expertise to ensure program objectives are in alignment with regulatory and commercial needs Collaborate with Clinical Development, Statistical Programming, Clinical Data Management, Regulatory Affairs, PSPV (Patient Safety and Pharmacovigilance) and Project Management Support innovative statistical techniques that will provide benefit to Horizon clinical development programs Contribute to go/no go decision guidance Review biostatistics and statistical programming tasks outsourced to vendors Ensure timeliness and quality of deliverables Adhere to standard operating procedures for GxP compliance Travel as needed to execute assigned responsibilities and tasks Required Education, Qualifications and Skills: 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. Good knowledge of clinical trial design, statistical analysis methods, and regulatory requirements in new drug development and registration Good knowledge of statistical analysis software (e.g., SAS, R) Experience with interventional clinical trials as a trial statistician Good knowledge of CDISC standards (e.g., CDAHS, SDTM, and ADaM) Professional, proactive demeanor 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 Good interpersonal and project management skills Good written and verbal communication skills Proficient in Microsoft Office Physical Demands (additions as needed) : Ability to sit and stand for extended periods of time Ability to carry, handle and reach for objects Manual dexterity to operate office equipment, e.g. computer, phones, etc. Horizon Core Values & Competencies : Growth Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovations 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. Our 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 role Compensation and Benefits Summary: The salary range for this role is $112,500.00-$137,500.00 annually. The base salary offered may vary based on the final candidate's qualifications. The level of this role may also change based on the final candidate's qualifications. In addition to the salary, this position is eligible for the benefits listed here and for the following plans: Salary Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity Grant, Corporate Bonus At 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.