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Biostatistician. International Project.

Biostatistician. International Project.

ALTEN Delivery Centre SpainChazo, Galicia, SPAIN
Hace 2 días
Descripción del trabajo

Are you looking for the next challenge in your career?

Would you like to be part of an exciting highly qualified team of professionals in an international environment?

We are currently looking for a qualified Biostatistician

Join an international division and work alongside with some of the most talented engineers from all over the world.

Your benefits :

  • Competitive Salary.
  • Long-term secure contract.
  • International Project with top technologies.
  • Possibility of working remotely with a flexible schedule.
  • Integration in a highly qualified team of professionals.
  • Travel abroad with your project.
  • Specialized training and continuous professional development.
  • Social benefits and flexible compensation plan.

Responsibilities :

  • Sample size or power calculations / simulations files (eg, East / SAS / R script as applicable) and documentation (eg, report / memo / respective section in the Statistical Analysis Plan (SAP) or any study document as applicable)
  • Statistical section of any study document (eg, study ID card, protocol, study report)
  • Statistical documentation for randomization plan and User Acceptance Test reports as applicable (eg, statistical documentation and specifications for Interactive Response Technology (IRT))
  • Documentation of statistical review of study documents as applicable (eg, Case Report Form, protocol, study risk management plan, IRT specifications, study report...) or project documents as applicable
  • DMC charter statistical documentation and SAP as applicable
  • Statistical surveillance reports when applicable (or data surveillance reports as applicable)
  • SAP and list of TL&Fs (Tables, Listings and Figures) for the study (including shell TL&Fs document for study-specific outputs) or pool of studies as applicable
  • Documentation of review of SDTM / ADAM documentation (mainly derived variables)
  • Documented instructions for statistical programmers
  • Statistical Status at Study Team Meetings (eg, slides) as applicable
  • Statistical programs in SAS or R and QC documentation
  • Dry-run and final reports outputs and interpretation
  • Documentation of statistical review of publications as applicable
  • Requirements :

  • Educated to MSc or higher level in a statistics discipline.
  • 3-5 years clinical trials experience Strong experience as lead statistician on clinical trials Phases 1 to 3.
  • Experience in the set-up and maintenance of data and programming standards, knowledge of CDISC and CRO.
  • Excellent communications skills in English Proactive and enthusiastic Team player Demonstrable experience of working in cross functional teams to achieve drug development goals
  • We positively value all work or study experience abroad.

    All positions require a high level of English (at least B2) - please send your detailed CV in English

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    Project International • Chazo, Galicia, SPAIN

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