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Bio Statistician Nijmegen Netherlands,  

Posted on : 14 May 2017

Project Description

Bio StatisticianAbout SynthonSynthon is an international pharmaceutical company, and a leader in the field of generic human medicines. Founded in 1991, Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company. Our mission is to make healthcare more affordable and to increaseaccess to important medicines through the provision of high quality generics and new biological and chemical entities - specifically in the therapeutic areas of oncology and autoimmune diseases. Currently our products are approved by regulatory agencies in more than 90 countries and marketed through strategic partnerships and – in dedicated areas – through direct sales.Synthon’s head office is based in Nijmegen, the Netherlands, and the company has affiliates in eight other countries. In 2016, it recorded a turnover of EUR 258 million. The company employs around 1,900 staff of whom over 500 work in Nijmegen.We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to what we do best: delivering affordable and innovative medicines to those in need.Job ProfileAs a (non-clinical) statistician you will coordinate, plan and carry out statistical activities for a variety of R&D projects including our antibody-drug conjugates program.You will provide our biopharmaceutical R&D department in-depth statistical support in the design and evaluation of analytical experiments and validation of complex analytical methods, including cell-based assays. Furthermore, for biotechnology-derived drug substances and drug products you will have a leading role in process development (Design of Experiments, Data Modeling), justification of control and specifications and problem solving (e.g. root cause investigations) from a statistical perspective. You will advise our preclinical R&D department on preclinical bioanalytical method development and validation, including PK and anti-drug antibody assays. Finally, you will be involved in the efficient handling and evaluation of big data sets generated by the biopharmaceutical R&D organization.You will closely collaborate with the responsible scientists and researchers and you will be in close contact with statisticians from the Clinical Development department, who aim to develop and implement good statistical practice as an integral part of biopharmaceutical R&D processes including the creation and implementation of standard tools and operating procedures. You will report to the director of Analytical Development within the biopharmaceutical R&D group.Your profileYour letter and CV will show that you have:A university degree in (bio)statistics or equivalentKnowledge of drug development processes. Familiarity with Design of Experiments, Quality by Design principles and Principal Component Analysis isa plusExperience with statistical software packages such as SAS/JMP and Minitab· Outstanding command of the English language in speaking and writing.In interviews you will be able to demonstrate that: You can clearly explain and communicate the statistical essentials relevant to analytical assays, process development and (pre)clinical experiments to different stakeholders (internal and external). You are used to working on multiple projects simultaneously. You take initiative to get tasks accomplished. In addition you have a creative and pragmatic approach.Important datesPlease send your application before June 9th 2017. The first round of interviews will take place on June 19th 2017, the second round of interviews will take place on June 23rd 2017.Information and applicationContract hours: part time or full time (32-40 hours.)Salary: depending on experience.Home base: Nijmegen.For further information please contact Ronald Smulders, director Analytical Development at tel. +31 (0)24 372 77 00.If you are interested in this challenging position, we look forward to your application via the apply button or link.


Nijmegen Netherlands

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