Ultragenyx Pharmaceuticals Inc. Novato , CA 94998
Posted 2 weeks ago
Position Summary:
ultracurious - Apply your biggest ideas in courageous ways
Reporting to the VP of Statistical programming, the Associate Director acts as statistical programming lead with accountability for various Ultragenyx products and study deliverables; This position will provide leadership and support to project teams on all statistical programming matters. Lead a Gene therapy projects for all programming deliverables through the project milestones from study start-up to regulatory submission 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 will lead the programming submission related activities.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
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
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
Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard 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-Hybrid
Ultragenyx Pharmaceuticals Inc.