About the job
Location: London/Hybrid
Reporting to: Head of Biostatistics
Orchard Therapeutics, a proud member of the Kyowa Kirin family, stands at the forefront of gene therapy, dedicated to revolutionizing the lives of patients grappling with rare disorders through pioneering gene therapies that leverage gene-modified hematopoietic stem cells (HSCs). Our global headquarters is situated in London, England, with a vibrant U.S. office in Boston, Massachusetts.
Job Summary:
As the Director of Biostatistics, you will take on a pivotal leadership role within a collaborative program team, offering an exciting opportunity to apply strategic statistical insights across all phases of clinical drug development in a fast-paced environment. You will steer the statistical strategy for our gene therapy development program, assuring data quality, compliance with regulatory and payer standards, and scientific integrity.
Key Responsibilities:
- Strategic Input: Partner with clinical, regulatory, and medical affairs teams to devise and execute a robust clinical development strategy.
- Regulatory Engagement: Lead the preparation of regulatory briefing documents, serve as the principal statistical consultant during regulatory discussions, and integrate feedback from regulatory authorities into study documents.
- Study Design: Provide expert input into program and study design, focusing on sample size justification and the specification of estimands.
- Analysis and Reporting: Spearhead the development of statistical analysis plans and ensure precise interpretation of analytical results in clinical study reports, regulatory submissions, and market access documents; contribute to publications and provide ad hoc analyses as needed.
- Operational Oversight: Efficiently manage relationships with vendors/CROs to guarantee high-quality deliverables, timely project execution, and effective resource allocation; review case report forms, study documents, protocol deviations, and support risk management efforts.