Director, Biostatistics

LocationLondon/Hybrid

Reporting to Head of Biostatistics

Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.

Job Summary

The Director, Biostatistics, is a hands-on leadership role within a cross-functional program team, providing an opportunity to contribute strategic statistical thinking to all aspects of clinical drug development in a dynamic environment. You will be responsible for the statistical strategy of a gene therapy development program, ensuring data and statistical quality, relevance to regulatory and payer requirements, and scientific validity.

Key Responsibilities

· Strategic input: Collaborate with clinical, regulatory and medical affairs colleagues to develop and implement a strategy for clinical development.

· Regulatory engagement: Contribute to regulatory briefing documents, act as the lead statistical consultant during regulatory meetings, address questions from regulatory authorities, and incorporate regulatory feedback into study documents.

· Study design: Provide technical input into program and study design, specifically sample size justification and the specification of estimands.

· Analysis and reporting: Lead the creation of statistical analysis plans/display shells, ensure accurate interpretation of analysis results in clinical study reports, regulatory submission documents, and market access dossiers; review and input into publications, including provision of ad hoc analyses as required.

· Operational oversight: Effectively manage vendors/CROs to ensure quality deliverables, adherence to timelines and efficient resource utilization, review case report forms and other study documents, review protocol deviations, contribute to risk management, and maintain the trial master file.