Director BioStatistics - Innovative Gene Therapy Start-up
The Director Biostatistics at Orchard Therapeutics is a key member of a cross-functional team working to provide transformative gene therapies to patients with rare diseases. Reporting to the Senior Director Biostatistics, this role provides a unique opportunity to contribute strategic statistical thinking to all aspects of clinical drug development in a dynamic environment.
In this role you will be expected to provide leadership and guidance as the lead statistician on one or more project teams. As a key member of the Program Team, you will be required to provide the statistical strategy for the project and be accountable for all statistical aspects of clinical studies and submissions paying particular regard to data and statistical quality, relevance to regulatory requirements, and scientific validity. This will be a hands-on role in which you will be expected to provide everything from high-level strategy to ad hoc analyses.
Key responsibilities will include:
- Collaboration with clinical and regulatory colleagues to develop strategy for clinical development.
- Statistical input into protocol development including advice on study design and writing the statistical section of the protocol.
- Review of CRFs and all data management documents.
- Writing and/or reviewing Statistical Analysis Plans including design of table shells
- Oversight of preparation of statistical outputs including interpretation of results of statistical analyses
- Statistical input into CSRs and submission documents including preparation of statistical methods and results sections incorporating statistical conclusions
- Response to questions from regulatory authorities
- Statistical representative on Program Team
- Attendance at regulatory meetings as key statistical consultant
- Management of vendors (CROs and/or consultants) providing statistical services
- Mentoring and development of junior staff both within the biometrics function and cross functionally
- Other activities as may be assigned
Extensive experience of working as a statistical leader in drug development
Expertise in a range of statistical methodologies with practical applications
Ability to communicate complex statistical concepts to non-statisticians
Demonstrable leadership, project management, and interpersonal skills
Experience in managing and working with CROs and consultants
Good knowledge of CDISC standards
Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
Self-starter with the ability to work on a cross-functional team
Experience working in rare diseases or in trials in small populations would be an advantage
Experience with Bayesian methodology would be an advantage
Education & skills
- MSc or PhD in statistics or related discipline
- Solid experience working as a statistician in drug development including significant interactions with regulatory authorities
- Proficiency with SAS required, experience with R an advantage
- Good knowledge of CDISC standards
- Excellent communication skills
- Proven leadership skills
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.