Bio Statistician - Netherlands
Want to know company name or location? Company managed [?]
- Our company is an international pharmaceutical company, and a leader in the field of generic human medicines.
- Founded in 1991,our company 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 increase access 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 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.
- 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.
- As 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 bio analytical 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.
- A university degree in (bio)statistics or equivalent
- Knowledge of drug development processes.
- Familiarity with Design of Experiments, Quality by Design principles and Principal Component Analysis is a plus
- Experience with statistical software packages such as SAS/JMP and Mini tab
- 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.