senior biostatistician in Lausanne

Coralyne Saint-Cirel, Geneva Professionals Health Care & Life Sciences
job type
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job details

lausanne, vaud
Life Sciences
job type
reference number
coralyne saint-cirel, geneva professionals health care & life sciences
058 201 54 40
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job description

Your role:

Provide statistical expertise with limited supervision on the design (clinical development plan, study SAP, ISSE/ISE SAP,…), analysis and interpretation of results on clinical project and/or CMC and bioanalytical projects in a regulated context.

Ensure that the planning and management of outsourced statistical deliverable (including statistical programming) are effectively performed and are conducted to the highest quality and in a timely manner

Ensure preparation of data package for file submission to health authorities with line management supervision. Produce responses to regulatory agency requests that maintain perspective and are within the appropriate context exhibiting sensitivity to issues raised.

Able to learn and apply state of the art statistical methodology for its project

Your profile: 

  • PhD or MS in Statistics, Biostatistics or related discipline
  • Fluent in English
  • 8-10 years’ experience in the Pharmaceutical/Biotechnology industry in pre-clinical or clinical development
  • Excellent knowledge of ICH/GCP and other relevant regulations
  • Experience supporting global regulatory submission required

Start date: ASAP