Location London/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.
Requirements
Education / Key Competencies
· 8+ years’ experience working as a statistician in drug development including experience as a project lead statistician and significant interactions with regulatory authorities.
· MSc or PhD in statistics or related discipline.
· Successful experience in regulatory submissions, including MAAs, NDAs/BLAs, and other filings.
· Ability to independently undertake new and highly complex tasks requiring advanced analytical thought.
· Excellent communication skills and in particular the ability to communicate complex statistical concepts to non-statisticians.
· Demonstrated experience in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness (experience with rare diseases, small populations or Bayesian methodology would be an advantage).
· Hands-on experience with SAS (experience with R is an advantage); good knowledge of CDISC standards.
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
RECRUITERS
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.
