Associate 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:

ultrafocused – Work together to fearlessly uncover new possibilities

Reporting to the Executive Director of Statistical programming, the Associate Director acts as statistical programming lead with accountability for various study(ies) deliverables within a program(s); This position will provide leadership and support to project teams on all statistical programming matters, in particular, integrated analyses, such as ISS, for upcoming regulatory submissions and approval and post marketing support. Collaborate with statisticians and programmers across to ensure high quality and timely statistical programming deliverables. This position will spearhead the statistical programming activities for multiple studies and products and will lead the programming submission related activities.

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 across all therapeutic areas
• Provide leadership 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, Data Management, Global Drug Safety, Regulatory, Project Management and other functions/staff to meet project deliverables and timelines for statistical data analysis and reporting
• 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
• Ensure proper implementation of Company data model and submission and analysis data standards
• Ensure consistency and efficiency in programming practices
• Implementation of standards and project management
• Foster team building and a collaborative work environment
• 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
• Minimum of 8 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
• Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
• Experience in integrating data from various sources, including ISS / ISE (Integrated Summary of Safety/Efficacy).
• Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regards to statistical programming processes, management of statistical programmers and customer management
• Excellent organizational skills and ability to prioritize tasks
• Vendor management experience
• Excellent communication and interpersonal skills #LI-CS1 #LI-Remote