Clinical CMC Statistician

£0.00 - £560 per day
  1. Permanent
  2. CMC
  3. Belgium
Rixensart, Walloon Brabant
Posting date: 27 Jun 2019
RA.EA.24057_1561631368

A top 10 global pharmaceutical company is currently recruiting a Clinical CMC Statistician. This organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in Belgium, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the clinical field.

Job Responsibilities:

  • Statistician Consultant for Non-Clinical Statistics in Technical R&D (TRD CMC Statistical Sciences)
  • Providing statistical expertise for the design and analysis of experiments whilst supporting process and analytical activities of vaccines product research and development.
  • Supporting the understanding of statistical aspects linked to ICHQ8 and Quality by Design principles.
  • Providing statistical support in close interaction with the project teams, the lab scientists, and experts, technicians, and statisticians.
  • Communicating results and conclusions to non-statisticians.
  • Ensuring quality and scientific pertinence of proposed solutions, implementation, execution, and outcomes.
  • Delivering statistical expertise supporting activities in compliance with current ICH / FDA guidelines and internal procedures.
  • Providing statistical input in order to ensure compliance with ICHQ8, QbD, and process evaluation/validation guidelines within R&D.
  • Planning and evaluation of experiments (DOE), sample size calculation, statistics for analytical method qualification etc.

Skills and Requirements:

  • University level in Sciences with at least post-graduate in statistics or equivalent experience.
  • ICT Skills (software, operating systems, hardware, etc.).
  • A mastery of the statistical theory of a broad spectrum of methodologies (DoE, modelling, measurement system analysis, quality control, multivariate analysis, and optimisation).
  • Demonstrates comfortable level of oral and written English and French
  • Previous knowledge on Good Laboratory/Manufacturing Practices and Quality by Design.
  • Experience within the pharmaceutical industry (non-clinical) or equivalent experience (chemistry, food, manufacturing industry).
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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