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Our client is a company with a quarter-century track record of delivering on the promise of biotechnology. Today, it is among the worlds leading biotech companies, with 12 protein-based products on the market for serious or life-threatening medical conditions and 20 projects in the pipeline. With its strength in all areas of the drug development process - from research and development to manufacturing and commercialization – they continue to transform the possibilities of biotechnology into improved realities for patients. This client has been voted one of the best employers to work for Year after year due to there outstanding benefits package and fantastic work environment.
They are currently seeking to expand their oncology statistical teams with a Senior Biostatistician.
Working on RITUXAN As the lead of a clinical assessment team, collaborates in the preparation and review of clinical assessments. Provide statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements. Working directly on submissions, one mid this year, one early next and following. Review all project protocols, author protocol statistical analysis sections and generate study randomizations. Develop study analysis plans. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, prepare data displays, and verify data accuracy and validity. Author’s statistical analysis results in the clinical study report. Responsible for seeing the report through the review process. Supplies statistical input for BLA submissions and in response to FDA questions. Provides support for investigator publications. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.
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