London, England, United Kingdom
The Director Biostatistics at Orchard Therapeutics is a key member of a cross-functional team working to provide transformative gene therapies to patients with rare diseases. Reporting to the Senior Director Biostatistics, this role provides a unique opportunity to contribute strategic statistical thinking to all aspects of clinical drug development in a dynamic environment.
In this role you will be expected to provide leadership and guidance as the lead statistician on one or more project teams. As a key member of the Program Team, you will be required to provide the statistical strategy for the project and be accountable for all statistical aspects of clinical studies and submissions paying particular regard to data and statistical quality, relevance to regulatory requirements, and scientific validity. This will be a hands-on role in which you will be expected to provide everything from high-level strategy to ad hoc analyses.
Key responsibilities will include:
Extensive experience of working as a statistical leader in drug development
Expertise in a range of statistical methodologies with practical applications
Ability to communicate complex statistical concepts to non-statisticians
Demonstrable leadership, project management, and interpersonal skills
Experience in managing and working with CROs and consultants
Good knowledge of CDISC standards
Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
Self-starter with the ability to work on a cross-functional team
Experience working in rare diseases or in trials in small populations would be an advantage
Experience with Bayesian methodology would be an advantage
Education & skills