Location: UK

Reporting to: Executive Director, Biostatistics

Job Summary

The Manager, 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 Executive Director, Biostatistics, this role provides a unique opportunity to contribute your statistical expertise to all aspects of clinical drug development in a dynamic environment.

Responsibilities

In this role you will be expected to take on the responsibilities of the lead statistician for a number of studies. As a key member of the Clinical Program Team, you will be required to provide input to all statistical aspects of clinical studies and submissions paying particular regard to data and statistical quality, relevance to regulatory requirements, and scientific validity.

Key responsibilities will include:

· Statistical input into protocol development including advice on study design, sample size calculations, and writing the statistical section of the protocol

· Review of Case Report Forms and all data management documents

· Writing and/or reviewing Statistical Analysis Plans including design of table shells

· Oversight of vendors providing statistical services, including updates to Trial Master Files as required

· Programming of TFLs to support CSRs, ad-hoc requests and regular regulatory safety updates

· Statistical input into CSRs and submission documents including preparation of statistical methods and input into results sections incorporating statistical conclusions

· Response to questions from regulatory authorities.

Requirements

Experience and Knowledge

· Solid experience working as a Statistician in drug development

· Experience in applying a range of statistical methodologies to clinical trial and real-world data

· Proficiency with SAS required, experience with R an advantage

· Good knowledge of CDISC standards

· Experience with Bayesian methodology would be an advantage

· Experience working in rare diseases or in trials in small populations would be an advantage.

Skills & Competencies

· Proven track record of providing on-time, high quality deliverables (including SAPs/shells, ad hoc TFLs, input into CSRs and regulatory documents)

· Excellent communication skills

· Good time management: ability to prioritize and adapt to rapidly changing requirements

· Self-starter with the ability to work on a cross-functional team

· Demonstrable project management and interpersonal skills

· Ability to communicate complex statistical concepts to non-statisticians

Education

· MSc or PhD in statistics or related discipline