Head of Biostatistics and Statistical Programming

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The Head of Biostatistics & Statistical Programming is responsible for the statistical aspects within the Global Development organization including clinical trials, experimental design, statistical analysis and reporting. This experienced and innovative biostatistician will work collaboratively with clinicians, regulatory leads, clinical operations, data managers, and biostatisticians in the planning and analysis of clinical studies and disease monitoring programs. This position will oversee Biostatistics/Epidemiology and Statistical Programming groups and will provide overall leadership to this team.  Reporting to the CMO, this role will sit on the CMO’s leadership team and play a critical role in the biostatistical strategic planning for all clinical programs at the company.   

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

• 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 
• 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  
• 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. 
• Mentor lead statisticians/epidemiologists in presenting the statistical concepts, evidence, interpretations, and logical arguments to the project team and senior management 
• Independently pursue analyses suggested by the data; Propose new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results 
• Contribute to the advancement of research in clinical trials methodology. Establish a healthy culture in the department, including collaboration and quality mindset 
• Develop and evaluate options for meeting project team goals under time and budgetary constraints and can change course quickly 

• 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 in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators 
• 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  

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