Manager, Statistical Programming
Company: Horizon Therapeutics
Location: San Leandro
Posted on: September 19, 2022
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.
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.
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
- 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.
Required Qualifications, Skills and Education:
- 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
- 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
- Excellent organizational skills and ability to prioritize
- Excellent communication and interpersonal skills.
Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- 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.by
Keywords: Horizon Therapeutics, San Leandro , Manager, Statistical Programming, Executive , San Leandro, California
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