Manager, Statistical Programming

Company: Horizon Therapeutics
Location: Bethesda
Posted on: May 23, 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 Working with the Biometrics staff, the candidate will provide programming support for Phase 1 to Phase 4 studies. The candidate will provide timely support to the project team on all statistical programming matters according to the project strategy, program SDTM, ADaM datasets, tables, figures and listings (TFLs) for the studies, write dataset specifications, provide quality control for datasets, tables, figures and listings, maintain records and timelines, identify and communicate changes in project requirements that may affect key deliverables. Responsibilities The primary role of this position is to assist or lead the statistical programming function that supports planned and ongoing clinical trials. Specifically, the Manager, statistical programming will be expected to: Involve in the programming activities on multiple projects/studies across various therapeutic areas, both internally and externally by CROs. Assist or lead multiple studies for Phase 1 to Phase 4. Create and review annotated CRF to SDTM datasets. Provide support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives. Function as a positive role model for setting high expectations for quality, creativity and project ownership. Works collaboratively with Clinical Operation, Statistics, Data Management, Global Drug Safety, Medical Affair, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting. Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers). Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate. Involve with the strategy for process improvement. Identify new tools to increase efficiency and quality and assist with implementing. Qualifications and Skills Required Master's Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related discipline. Minimum of 2-7 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry. Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus. Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies. Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programming projects. Excellent organizational skills and ability to prioritize tasks. Excellent communication and interpersonal skills. 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 $130,500.00-$159,500.00 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.

Keywords: Horizon Therapeutics, Bethesda , Manager, Statistical Programming, Executive , Bethesda, Maryland