Manager Biostatistician ** Application for Clinical Trials ** Switzerland

Location
Lausanne - Geneva
Salary
Competitive
Posted
09 Jan 2019
Closes
09 Feb 2019
Ref
OD/10393 C

Manager Biostatistician ** Application for Clinical Trials ** Switzerland

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We are pleased to present to you this role with a global pharmaceutical and healthcare company that is expanding its biologicals business unit due to pipeline expansion in Switzerland.

We are seeking a Manager Biostatistician who will provide statistical expertise form Study Design, Stats Plan to readout, NDA/MAAs, HA Queries for Studies running worldwide. The role is a full time role and is based in the beautiful Lausanne – Geneva region of Switzerland. It is well-funded and comes with a very competitive salary, bonus as well as normal Swiss benefits.

The company is expanding its operations due to a larger number of projects coming into the R&D pipeline and 2 readouts for regulatory submissions coming through as we speak, of which you and a team of biostatisticians will work on.

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. SAS expertise is required as well as good knowledge of EMA, ICH, FDA etc. relevant documents. You would also speak French and English.

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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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Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

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All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

Keywords: Biostatistics, Bio-statistics, Biostatistician, Bio-statistician, Jobs in Biostatistics, Jobs in Bio stats, 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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