Director, Statistical Programming
Ultragenyx
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $206,600 - $255,200 per year
Job Level
About the role
- 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
Requirements
- 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
Benefits
- Generous vacation time and public holidays observed by the company
- Volunteer days
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
SASRS-PlusCDISCSDTMADaMeCTDDefine.xmlstatistical programmingdata analysis
Soft Skills
leadershipcommunicationcollaborationstrategic thinkingmotivationconflict resolutionproject managementself-directioncustomer managementinformation flow