Associate Director, Statistical Programming

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare disease treatments, as an Associate Director of Statistical Programming. Reporting to the Executive Director, you will lead statistical programming activities for multiple studies and products, ensuring high-quality deliverables for regulatory submissions and post-marketing support. This remote position requires collaboration with various teams and strong SAS programming skills. The role demands experience in CDISC standards, data integration, and vendor management. Ultragenyx offers a competitive salary, annual bonus, equity incentives, and a comprehensive benefits package including generous vacation time, volunteer days, and professional development opportunities.

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

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

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
• Annual bonus
• Equity incentives