OPTION SWISS *** Manager Biostatistician *** from Study Design to Readout, Analyses for NDA/MAAs subs and HA Queries

OPTION SWISS *** Manager Biostatistician *** from Study Design to Readout, Analyses for NDA/MAAs subs and HA Queries

We are seeking a Manager Biostatistician who will provide statistical expertise from Study Design, Stats Plan to Readout, NDA/MAAs, HA Queries, for Studies running Worldwide.

The role is with a global pharmaceutical and healthcare company that is expanding its biologicals business unit due to pipeline expansion, in Switzerland. The role is located in Lausanne – Geneva region of Switzerland, it is well-funded and comes with a very competitive salary, bonus as well as normal Swiss benefits.

Responsibilities will include being accountable for statistical deliverables of clinical studies, so you will contribute to the development plans, concept sheets, protocols, readouts, statistical analyses, Clinical Study Reports (CSRs), ISS/ISE, and co-preparation of HA Scientific Advice Briefing Books, Responses to HA Queries etc. You would manage GCP compliance, and standardization in collaboration with cross-functional colleagues, as well as from a Stats point of view for external partners, CRO selection / management, and inspection readiness.

If you have several years of experience in the Pharmaceutical / Biopharmaceutical industry or with a CRO as a Bio-Statistician, then this is an opportunity right for you.

Experience with submissions in Europe and the US would be an asset. Strong SAS expertise is required as well as good knowledge of EMA, ICH, FDA etc. relevant documents.

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If you wish to apply for this role, please send your CV with a covering note to oli@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Matt or Oli in the London office on +44 (0)20 7801 3380 or +44 (0)20 7801 3388.
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About Advanced

Advanced Search and Selection Ltd and our parent ADV Talent Partners Ltd has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas.
We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com

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Keywords: Bioatatistics, Bio-statistics, Biostatistician, Bio-statistician, Jobs in Biostatistics, Jobs in Biostats, Biopharmaceutical, Pharmaceutical, Pharma, Biopharma, Manager Biostatistician, Statistics, Statistician, Suisse, Swiss, Switzerland, Stats, Data Management, Data Analysis, Clinical Study, Clinical Trials. 

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