Ref: 133| Posted: 16th Mar 2023

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Terumo Aortic have an exciting opportunity for an experienced Biostatistician to join our Clinical Affairs department. The successful individual will be responsible for providing statistical and data management support to clinical study teams based in both Glasgow and Florida.

Key Duties

  • Collaborates in the design, analysis, and reporting of clinical studies  
  • Perform power and sample size calculations and develop the statistical sections of the protocol
  • Prepare, review, and execute Statistical Analysis Plans (SAPs) throughout study lifecycle
  • Participate in development of database clinical trial data specifications, including eCRF design, user acceptance testing, edit rules/checks, query logic, and data validations
  • Participate in the development of statistical programs as necessary to perform analyses and prepare Tables, Listings and Figures and/or data displays (such as writing scripts, macros, and SQL queries to assist in data processing)
  • Provide quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP
  • Ensures proper study closeout by documenting and archiving study related materials
  • Provides training and advice on statistical methodology to other departments or members of the clinical affairs team
  • Undertake training to develop competency in and compliance with ICH GCP, the Medical Devices Regulation 2017/745 (MDR), ISO 14155, internal procedural documents and any other relevant regulatory requirements
  • Other tasks as deemed necessary by the business

Qualifications and Experience


  • Bachelor’s degree in relevant field or equivalent experience
  • Experience in a clinical research environment
  • Experience in SAS programming
  • Excellent knowledge of statistical theory including experimental design, meta-analysis, categorical data analysis, analysis of variance (covariance), survival analysis, and non-parametric methods
  • Experience in peer review of existing study papers
  • Effective written and verbal communication skills
  • Be able to work simultaneously across multiple projects


  • MS or PhD in Biostatistics or related field.
  • Experience of medical device trials
  • Practical knowledge of relevant clinical research regulatory guidance and standards for statistical considerations (e.g. ICHE9 Statistical Principles for Clinical Trials, BSI/FDA)
  • Experience in the preparation of Clinical Evaluation Reports as required under MDR
  • Working knowledge of |GCP, Clinical trial process, MDR and related regulatory requirements and terminology.
  • Working knowledge of medical writing processes and requirements