Principal Biostatistician, Early Phase FSP

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Company: RBW Consulting LLP
Category: Computer and Mathematical Occupations
Published on 2021-08-02 18:04:55

The world’s largest biometric specialist Clinical Research Organisation

Geoff King at RBW Consulting is working with the world’s largest biometric specialist Clinical Research Organisation (CRO) in the recruitment of a Principal Biostatisticians to join their Flexible Service Provider team as they continue to support a number of the world’s largest pharmaceutical and cutting-edge biotechnology companies.

As a Principal Biostatistician you will have the opportunity to work with a high-profile sponsor across a range of non-oncology studies in phase I-II clinical trials. Fully home based in UK, Ireland, Spain, Germany, France and Switzerland.

For over 30 years this specialist CRO has focused on delivering high quality biostatistics and programming support to life science companies across the globe and now boast offices in the UK, Europe, America and India as a world leader in their field.

Priding themselves in career development, training and an incredibly supportive management team the company continue to go from strength to strength seeing business growth throughout 2020 and continued staffing needs required throughout 2021 due to a number of new studies and sponsors being secured.

Main duties & responsibilities:

  • Development of study protocols, including participation in study design discussions and sample size calculations.
  • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications.
  • Performing statistical analyses and interpreting statistical results.
  • Preparing clinical study reports, including integrated summaries for submissions (ISS/ISE), other documents for Health Authorities, Publication or exploratory purpose.
  • Leading study activities when called upon.
  • Perform QC and oversight of other third parties' contributions as appropriate.
  • Key requirements:

  • BSc in Statistics/Biostatistics (or equivalent).
  • At least 6 years of relevant industry experience.
  • Understanding of clinical drug development process, relevant disease areas, endpoints and different study designs.
  • Awareness of industry and project standards & ICH guidelines.
  • Excellent verbal and written communication skills.
  • A comprehensive job description is available upon request.

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