Please find the requirement currently open.
Stamford, CT
12 months
Open
They have to have Phase I exp. and a min. of 2-3 years exp. In Pharma or CRO.
• Statistical design and analysis of Phase 1 studies
• Communicate with CRO statisticians in planning and reviewing Phase 1 statistical analysis
• Interact closely with Clinical Pharmacology colleagues in order to meet tight project deliverablesCollaborates and interacts with the clinical/medical staff utilizing technical knowledge and experience in the design, development, analysis, and reporting of Phase I clinical studies
• Provides input into protocol development and review
• Prepares analytical plans and conducts statistical analysis of Phase 1 clinical data using appropriate statistical models and methods
• Works with CRO statistical colleagues in planning the programming necessary to effectively analyze, summarize, and display data from Phase 1 clinical studies Review CRO provided statistical deliverables of 2 Butrans bioequivalence studies
• Review and comment on draft TLGs and analysis data sets
• Review clinical study reports for statistical accuracy
• Assist in the design of at least 2 HYD Phase 1 studies. Develop the statistical sections of these protocols.
• Review CRO provided statistical deliverables of ONU abuse liability studies. Review and comment on draft TLGs and analysis data sets. Review clinical study reports for statistical accuracy.
• Provide statistical consultation to Clinical Pharmacology staff, as needed.
• Statistical Consultant candidate must be experienced in Phase 1 studies. Critical deliverables for the Statistical
Please respond with Resume, Rate, Current Location and Phone numbers of the Consultant. Make sure the Consultant's skills match the requirement.
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