- Leads one or multiple studies
- Consistently works with cross- functional areas
- Directs and controls multiple deliverables
- In-depth knowledge of functional area, industry standards and company goals
- 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
- Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline
- Minimum of 6 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
Senior Manager, Statistical Programming - Novato, United States - Ultragenyx Pharmaceuticals Inc.
Description
Position Summary
ultracurious - Apply your biggest ideas in courageous ways
Reporting to Director of Statistical programming, the Senior Manager acts as statistical programming lead with accountability for various Ultragenyx studies and deliverables; This position will provide leadership and support to project teams on all statistical programming matters with help from the supervisor. Lead one or more studies 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 one or 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.