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.
Company: Horizon Therapeutics USA, Inc.
Location: Two Tower Place, 12th Floor, South San Francisco, CA 94080
Position Title: Manager, Statistical Programming
Annual Salary Range: $135,000 - $160,000
Hours: Monday - Friday, 8:00 am to 5:00 pm 40 Hours/ Week
Summary of Duties: Work with the Biometrics staff to provide programming support for Phase 1 to Phase 4 studies. 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 specification. 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. Assist or lead the statistical programming function that supports planned and ongoing clinical trials. Be involved in the programming activities on multiple projects/studies across various therapeutic areas, both internally and externally by CROs. Assist or lead multiple studies from 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. May telecommute up to 60% of the week within a commutable distance from the Company's South San Francisco, CA office and report in person to the Company's South San Francisco, CA location.
Qualifications: The position requires a Master's degree in Statistics, Biostatistics, Mathematics, or a related discipline and two (2) years of experience in the job offered, as a Statistical Analyst, Statistical Programming Consultant, or a related occupation.
The position requires two (2) years of experience with following: Statistical Analysis specifically ANCOVA, Proc Univariate and Proc Mixed procedure of SAS included block, treatments, time and treatment by time interactions in the model; Clinical Trial Analysis with integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) analysis; FDA and PMDA submission experience; ADAM datasets creation with ADSL, ADTTE, ADLB with toxicity grading per CTCAE; CDISC including SDTM, ADAM and controlled terminologies; statistical programming processes, and management of statistical programming projects. Must have experience with the following: Therapeutic Area; Inflammation, Rheumatology, and Biostatistical Programming Studio (BPS); Global Drug Safety Patient Profile creation; and Advanced SAS programming skills and experience in other statistical software, such as R, Python, SQL, GCP and S-Plus. Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- 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.
- Data Analysis
- Benchmarking (Project Management)