Associate Director, Statistical Programming
Company: Horizon Therapeutics
Location: San Mateo
Posted on: May 13, 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.
Responsible for the development and maintenance of statistical
programming functions to support various projects. Manages
programmers and CROs, oversees programming activities related to
certain clinical programs and studies. Help with the development of
the programming strategy works in the development of the SAS
programming infrastructure and coordinates the effort across
therapeutic areas to identify, develop and implement departmental
standards, applications, and processes. Provides timely support to
the project teams on statistical programming matters according to
the project strategies and is responsible for addressing all
administrative functions required for project strategies and is
responsible for addressing all administrative functions required
for project management and milestones, identifying and
communicating changes in project requirements that may affect key
deliverables at the project level.
The primary role of this position is to assist the statistical
programming function that supports planned and ongoing clinical
trials. Specifically, the Associate Director, statistical
programming will be expected to:
- Help to build the statistical programming function, such as
developing processes, developing relationships with key
stakeholders, recruiting programmers, enforcing standards as the
- Responsible for the development, review, validation, and
execution of SAS programs to generate Tables, Figures, and
- Create and review annotated CRF and SDTM datasets.
- Translate the SAP into programming specifications for analysis
- Review key study-related documents produced by other functions,
such as case report forms.
- Review the DMP, SAP, and TFL specifications, and provide
feedback to the statisticians and data managers.
- Develop, review, validate, and execute SAS programs to generate
standard (SDTM and ADaM) and non-standard (custom study-specific)
datasets to be included in reports for submission to regulatory
agencies, publications, and other communications.
- Assist with SAS Programming Infrastructure including the
design, creation, and validation of global SAS macros and utilities
that streamline operations to increase programming efficiency.
Support the development of statistical programming processes to
ensure the best quality statistical outputs.
- Manage the programming activities on multiple projects and
studies across various therapeutic areas, programmed either
internally or externally by CROs.
- 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.
- Work collaboratively with Clinical Operation, Data Management,
Statistics, Global Drug Safety, Medical Affairs, 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 functions for the development
and maintenance of the data review and reporting tools, and any
other statistical applications as appropriate.
- Assist in setting the strategy for process improvement.
- Identify new tools to increase efficiency and quality and
assist with implementation.
Required Qualifications, Skills, and Education:
- Master's Degree in Statistics, Biostatistics, Mathematics,
Epidemiology, or related discipline.
- Minimum of 7-12 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.
- Experience in developing SAS macros to standardize the workflow
and internal processes.
- Self-directed, technically strong, and a recognized leader
maintaining a strategic perspective 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.
Keywords: Horizon Therapeutics, San Mateo , Associate Director, Statistical Programming, Executive , San Mateo, California
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