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The Director of Statistical Programming will spearhead the statistical programming activities for multiple studies and will lead the programming submission-related activities. This individual will lead all programming deliverables through the project milestones from study start-up to regulatory submission and post-marketing support. This role provides leadership and support to project teams on all statistical programming matters by collaborating with statisticians, data managers, and others to ensure high-quality and timely statistical programming deliverables.
Work Model:Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:- Manage all programming activities on one or multiple projects/studies across all therapeutic areas, both internally and externally by CROs
- Provide leadership in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage, and align people with the company's strategic objectives
- Work collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory, Project Management, and other functions/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)
- Works with other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
- Participate in the statistical programming training as appropriate
- Ensure proper implementation of company data standards and industry submission data standards
- Implement standards and project management
- Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports
- Ensure project milestones are met to facilitate decision-making and address business needs
- Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, or related discipline preferred
- Minimum of 10 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 of CDISC including SDTM, ADaM, and controlled terminologies
- Direct experience with eCTD submissions (FDA/EMA/PMDA) and creating Define.xml and Reviewer’s Guide.
- Self-directed, technically strong, and a recognized leader maintaining a strategic perspective regarding statistical programming processes, management of statistical programmers, and customer management
- Vendor management experience
#LI-CS1 #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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