Director, Biostatistics
About the role
Position Summary:
ultracurious – Apply your biggest ideas in courageous ways
The Director of Biostatistics acts as program statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data quality assurance.
The Director of Biostatistics contributes to identifying, developing, and implementing departmental standards, applications, processes, and training. Provides timely support to the project teams on all statistical matters according to the project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level.
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:
- Lead in product / indication level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
- Contribute to study level tasks from statistics perspective, including: