Senior Biostatistics Lead – Gene Therapy Programs

Orchard Therapeutics plc.; Greater London; Hybrid; GBP 120,000 - 180,000; Full time

Job summary

Orchard Therapeutics plc. in London seeks a Director of Biostatistics to shape the statistical strategy across a gene therapy development program.

You will provide hands-on leadership within a cross-functional team, ensuring data quality, regulatory relevance, and scientific validity. The role requires 8+ years in drug development statistics, MSc/PhD, and strong regulatory interaction skills, with SAS and CDISC experience preferred.

Qualifications

• 8+ years of experience as a statistician in drug development and leadership roles.
• MSc or PhD in statistics or related discipline.
• Experience with regulatory submissions (MAAs, NDAs/BLAs) and interactions with authorities.

Responsibilities

• Collaborate with clinical, regulatory and medical affairs to develop and implement statistical strategy for clinical development.
• Lead regulatory engagement and serve as the lead statistical consultant in regulatory meetings.
• Provide input on study design, including sample size justification and estimands.
• Lead creation of statistical analysis plans and study reports; contribute to publications.
• Oversee vendors/CROs, ensure timelines and quality deliverables, and manage trial/master file documents.

Skills

Statistical leadership

Regulatory interaction

Communication skills

Analytical thinking

Bayesian methods

Education

MSc or PhD in statistics

Tools

SAS

R

CDISC standards

Job description

Orchard Therapeutics plc. in London seeks a Director of Biostatistics to shape the statistical strategy across a gene therapy development program.

You will provide hands-on leadership within a cross-functional team, ensuring data quality, regulatory relevance, and scientific validity. The role requires 8+ years in drug development statistics, MSc/PhD, and strong regulatory interaction skills, with SAS and CDISC experience preferred.