Location : Eli Lilly & Company Ltd., Lilly Research Centre, Windlesham,
Surrey, UK
Eli Lilly and Company is a world leading pharmaceutical organisation, with a
multi-billion dollar turnover worldwide and an international reputation for
quality and innovation. We are a premier company in the research, development
and manufacturing of novel ethical pharmaceutical products across the major
therapeutic areas.
Clinical Pharmacology Statistician, Statistical Sciences.
The Clinical Pharmacology Statistician will be responsible for providing the
statistical solutions in support of the clinical trial activity and data
analysis related to the Clinical Pharmacology department located at the Lilly
Research Centre. The statistician will support drug development involving
initial testing in normal human subjects. The statistician will participate
in the scientific discussion for planning and designing clinical pharmacology
studies, reviewing clinical reports, making suggestions for improvement, and
liaising with contract research organisations (CRO). In this capacity the
statistician will interact with clinical pharmacologists, pharmacokineticists,
and clinical research administrators in developing protocols to investigate
the safety, evaluate the pharmacokinetics, assess the pharmacodynamic effects,
and determine optimal dosing regimens for subsequent large-scale studies in
patients.
Educational Requirements and Work Experience:
· M.Sc. or PhD. in a statistics related degree and ideally at least 3 years
relevant experience working with early phase clinical data, either within the
pharmaceutical industry or a related organisation.
Nature of the work:
· Provide input, through statistical thinking and education, into clinical
pharmacology studies being conducted in the European region to ensure
consistency with the global clinical plan and strategy.
· Where data management and statistical analysis is being carried out by a
CRO, the statistician will liaise with the CRO to provide analysis plans,
consultation, and determine the integrity of the statistical evaluation
performed.
· The statistician will provide analyses for bioequivalence testing, dose
proportionality, first human dose studies, multiple dose studies and other
studies in accordance with regulatory requirements.
· The statistician will support special-population and market-driven
studies conducted by research physicians both internally and externally, such
as drug tolerance in hepatic- or renal-impaired subjects.
· The statistician will design and evaluate studies directed to assess the
interaction of drugs, based on pharmacokinetic and/or pharmacodynamic
responses.
· The statistician will collaborate in the preparation and writing of
registration quality scientific reports and publishable manuscripts.
· The statistician will collaborate with other statisticians to promote
statistics within Lilly Clinical Pharmacology based in the USA, Belgium, and
Singapore.
If you are interested, please send your CV to;
Martin Birkett
Senior Statistician
Eli Lilly and Company Ltd.
Lilly Research Centre
Erl Wood Manor
Windlesham
Surrey
GU20 6PH
UK
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