Director, Statistical Programming

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

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:

1. Manage all programming activities on one or multiple projects/studies across all therapeutic areas, both internally and externally by CROs 
2. Provide leadership in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage, and align people with the company's strategic objectives 
3. 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 
4. Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers) 
5. Works with other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate 
6. Participate in the statistical programming training as appropriate 
7. Ensure proper implementation of company data standards and industry submission data standards 
8. Implement standards and project management 
9. 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  
10. Ensure project milestones are met to facilitate decision-making and address business needs 

Requirements:

1. Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, or related discipline preferred 
2. Minimum of 10 years of clinical trial programming experience in the biotechnology, pharmaceutical, or health-related industry 
3. Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus 
4. Experience and in-depth knowledge of CDISC including SDTM, ADaM, and controlled terminologies 
5. Direct experience with eCTD submissions (FDA/EMA/PMDA) and creating Define.xml and Reviewer’s Guide. 
6. Self-directed, technically strong, and a recognized leader maintaining a strategic perspective regarding statistical programming pr