Ultragenyx is looking for a Head of Biostatistics & Statistical Programming to lead the statistical aspects of their clinical trials, experimental design, analysis, and reporting to support their mission of leading the future of rare disease medicine.
Requirements
- Ph.D. in Applied Statistics, Statistics, or Biostatistics
- 15+ years of experience applying statistics and epidemiology methods in a biopharmaceutical industry
- Demonstrated statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, analysis of clinical imaging results such as X-Ray
- Experience in designs and Bayesian data analyses, rare disease global clinical development and applying epidemiological methodology to support delivering rare disease therapies for patients
- Has influenced external environment through contributions to presentations, and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical and epidemiological methodologies
- Experience with regulatory guidance and guidelines, and general knowledge of industry best practices.
- Expert knowledge in Health Authority interactions and submission strategies, IND/BLA/NDA/MAA submissions, and writing technical and management documents
Responsibilities
- Lead the Biostatistics/Epidemiology and Statistical Programming teams
- Ensure statistical integrity of clinical studies conducted to support projects across the portfolio
- Set strategy for the department, including enhancing technical expertise in support of drug development and enabling development of staff
- Provide statistically/epidemiologically sound scientific methodology leadership in experimental design and data analyses
- Review statistical analysis sections of protocols, statistical analysis plans, study reports, regulatory documents or scientific publications, generates/reviews study sample size/power estimations
- Provide leadership in the interpretation and reporting of the results of statistical analyses.
- Independently pursue analyses suggested by the data; Propose new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results
Other
- Be a hero for our rare disease patients
- Work together to fearlessly uncover new possibilities
- Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
- Build/drive relationships and teamwork across the Biostatistics and Programming teams in support of the programs ensuring proper statistical strategies, and understanding of priorities between the project teams and the teams
- Mentor lead statisticians/epidemiologists in presenting the statistical concepts, evidence, interpretations, and logical arguments to the project team and senior management
