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Statistician – Data Analyst (H/F/X)

February 24th 2021

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs. The company holds a unique position on the market with all its laboratories on one site, 210 highly qualified professionals and over 35 years’ expertise at the forefront of analytical sciences. The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Mission Description

You will report to the Scientific Data Manager
In this role, you will integrate the Scientific Data Management team and give support to the Scientific Operations (SO) and the Quality Assurance (QA) departments. You will take part in implementation of statistical and data management good practices at Quality Assistance.
You will be accountable for the following tasks

  • Managing statistical data analysis related to day-to-day activities of the SO (e.g. QbD, DoE, outliers, OOT, OOS, … )
  • Writing statistical analysis protocols
  • Validating statistical reports
  • Supporting the Principal Statistician in developing and implementing statistical applications
  • Organizing data generated by the laboratory
  • Managing internal communication on statistical questions
  • Ensuring a regulatory and bibliographic watch on statistical subject matters

Candidate profile

Scientific degree with a specialisation in Statistics, Biostatistics or Data analysis
Required

  • Excellent numerical and analytical skills
  • Knowledge of data analysis/statistical tools (e.g. R, SAS, JMP, others)
  • Experience of statistical methodologies and data analysis techniques in relation with Bio/Pharma domain
  • Ability to produce clear graphical representations and data visualisations
  • Familiarity with scientific databases (knowledge of e.g. Oracle, MS Access, SQL, others)
  • Skills in data modelling, data cleansing techniques
  • Capacity to develop and document procedures and workflows  Ability to work accurately (sense for detail) and efficiently in a multi-task environment
  • Ability to work in a French speaking environment (ability to communicate in French, read and write in French (scientific documents, reports, protocols and mails)
  • Ability to write correctly in English (scientific documents, reports, protocols and mails)  Ability to take initiative, prioritise and work under set deadlines to meet objectives  Team player

Plus

  • Working experience in a GMP environment and/or working experience in the pharmaceutical industry
  • Laboratory skills About Quality Assistance

Offer

  • We are a true career partner.
  • We accelerate people’s access to new medicines.
  • We offer an inspiring work-life balance in a human scale environment.
  • We care about mutual respect, assistance and communication.
  • We listen to your needs and your suggestions.
  • We offer a market-competitive remuneration package including numerous fringe benefits. You will also be provided with a company car.

Contact Details

Send your application now (JOB247) to Mrs Isabelle Lebrun, Talent Acquisition Manager, to recrutement@quality-assistance.be or consult the Careers page on our website http://www.quality-assistance.com/careers/jobs.

Address: Technoparc de Thudinie 2, 6536 Donstiennes, Belgium