Keyword
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The successful candidate will be a qualified, professional statistician, who is required to lead the analysis of clinical diagnostic and survival studies. The analysis must be of the appropriate standard for publication in top bio/medical journals and for submission to regulatory authorities. Advice on the design of prospective studies will also be required. Effective team working with regulatory affairs specialists, R&D scientists and clinical researchers will be necessary. Additional duties will include statistical guidance on suitable quality control and quality assurance protocols in the production of medical diagnostic devices.
Essential skills required are:
Desirable skills are:
The successful candidate will be a Grade B clinical scientist who will be responsible for the handling, organisation, analysis and storage of biological samples in a variety of clinical studies. They will be responsible for the supervision of other staff involved in the above. They will also be responsible for providing informed assessments and constructive comments on new assays, while under development.
A scientist is required to take responsibility for the collection, organisation and presentation of in vitro diagnostic clinical data to the relevant regulatory authorities. Collaboration with regulatory affairs specialists, R&D scientists, clinical researchers and bio-statisticians will be necessary.
Experience in clinical studies, in vitro diagnostics and FDA submissions
The successful candidate will be involved in providing safe assayed plasma delivered products, internally and for bulk sale. They will need to be familiar with all company systems and regulations, including LINE 500, Q Pulse, QA & RA and employ them as required. Also they will write, review and update worksheets, PMPs and GEN SOPS. The role will include dealing with complaints and CAPA's as appropriate, to be the point of contact for internal customers and to aim towards process improvement in all aspects of their work. Full training will be provided.
Desirable skills required are: