Orchard Therapeutics

Director

• Collaborate with clinical, regulatory and medical affairs colleagues to develop and implement a strategy for clinical development.
• 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.
• Provide technical input into program and study design, specifically sample size justification and the specification of estimands.
• 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.
• 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.

Director, Biostatistics