Biostatistics Director, Gene Therapy Strategy

Orchard Therapeutics - U.S.; Greater London; Hybrid; GBP 140,000 - 210,000; Full time

Job summary

Orchard Therapeutics, a Kyowa Kirin company, is seeking a Senior Director, Biostatistics to lead the Biostatistics function within the Medical/Clinical Development team. You will guide statistical strategy, ensure robust methodologies, and interact with regulators and internal stakeholders worldwide.

The role reports to the VP, Clinical Science and leads statisticians and programmers. Responsibilities include team building, strategic leadership for development plans, regulatory submissions, and

Qualifications

• 15+ years' experience as a statistician in drug development with regulatory interactions, including at least 5 years in a management role.

Responsibilities

• Build and lead a high-performing Biostatistics team with budget oversight.
• Provide strategic input into clinical development plans and regulatory submissions.
• Collaborate with clinical, regulatory, medical affairs, and external partners.
• Explore and implement novel statistical methodologies for gene therapy and rare diseases.
• Represent Orchard as lead statistician in regulatory engagements.
• Provide statistical input on study design, estimands, SAP/shells, vendor oversight, and result interpretation.

Skills

Statistical leadership

Clinical statistics

SAS

CDISC

Bayesian methods

Regulatory interactions

Education

MSc/PhD in statistics

Tools

SAS

R

Job description

Orchard Therapeutics, a Kyowa Kirin company, is seeking a Senior Director, Biostatistics to lead the Biostatistics function within the Medical/Clinical Development team. You will guide statistical strategy, ensure robust methodologies, and interact with regulators and internal stakeholders worldwide.

The role reports to the VP, Clinical Science and leads statisticians and programmers. Responsibilities include team building, strategic leadership for development plans, regulatory submissions, and