Lead Statistician

Location
London, United Kingdom
Posted
Jun 09, 2021
Ref
156D136F43
Required Education
Bachelors Degree
Position Type
Full time
Reporting to: Senior Director Biostatistics

The Lead Statistician 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 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 Study 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 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

Requirements

Job Requirements
  • Expertise in a range of statistical methodologies with practical applications
  • Ability to communicate complex statistical concepts to non-statisticians
  • Demonstrable project management and interpersonal skills
  • Good knowledge of CDISC standards
  • 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
  • Proficiency with SAS required, experience with R an advantage
  • Good knowledge of CDISC standards
  • Excellent communication skills