Senior Statistician - Bios4


Full-time

London, England, United Kingdom

Biostatistics

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

Requirements

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

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

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.