Vice President, Biostatistics
Posted on Apr 6, 2021 by Ultragenyx Pharmaceutical Inc.
The Vice President is responsible for the statistical aspects of clinical trials, including experimental design, statistical analysis, and reporting. This experienced, progressive biostatistician will work collaboratively with clinicians, data managers, biostatisticians, and statistical programmers in the planning and analysis of clinical studies. This position will also oversee and provide leadership to a team of 10 biostatisticians, 2 statistical consultants. The VP, Biostatistics will play a key role in the strategic planning for all clinical programs as well as the growth and development of this important segment of the company.
Responsibilities including, but not limited to:
The qualified candidate must have a minimum of 15+ years of experience in applying statistics in a biopharmaceutical industry.
The preferred candidate will have excellent 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 echocardiograms, SAS programming, and other relevant software applications, statistical methodologies, theories and analysis including adaptive designs and Bayesian analysis.
Demonstrated expertise in Rare Disease global clinical development (preferred)
The preferred candidate will have a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.
Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical/medical experts, and external collaborators.
The candidate must have experience within a team environment, and have good leadership and managerial skills, collaborative and negotiation skills and demonstrate self-motivation.
Deep understanding of regulatory guidance and guidelines, as well as general knowledge of industry best practices and standards. Expert knowledge in Health Authority interactions and submission strategies.
Prior experience with IND/BLA/NDA/MAA submissions.
Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.
Experience in writing technical and management documents, reports and presentations.
Ph.D. Applied Statistics, Statistics, or Biostatistics required