Director, Statistical Programming

Ultragenyx Pharmaceutical

1d•Remote

About The Position

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.

Requirements

Master’s Degree in Statistics, Computer Science, Mathematics, Engineering, or related discipline preferred
Minimum of 10 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 and S-Plus
Experience and in-depth knowledge of CDISC including SDTM, ADaM, and controlled terminologies
Direct experience with eCTD submissions (FDA/EMA/PMDA) and creating Define.xml and Reviewer’s Guide.
Self-directed, technically strong, and a recognized leader maintaining a strategic perspective regarding statistical programming processes, management of statistical programmers, and customer management
Vendor management experience

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
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
Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers)
Works with other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
Participate in the statistical programming training as appropriate
Ensure proper implementation of company data standards and industry submission data standards
Implement standards and project management
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