Orchard Therapeutics

Director, Biostatistics

Orchard Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: London • United Kingdom

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Job Level

Lead

About the role

  • Collaborate with clinical, regulatory and medical affairs colleagues to develop and implement a strategy for clinical development.
  • 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.
  • Provide technical input into program and study design, specifically sample size justification and the specification of estimands.
  • 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.
  • 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

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
statistical analysissample size justificationestimands specificationregulatory submissionsstatistical methodologiesclinical trial designdata interpretationad hoc analysesrisk managementproject lead statistician
Soft Skills
communication skillsanalytical thinkingcollaborationvendor managementproblem-solvingresource utilizationattention to detailleadershiptime managementadaptability
Certifications
MSc in statisticsPhD in statistics