Provide biostatistical oversight role on one or more projects. Develop protocols, review case report forms (CRFs) and prepare analysis plans. Communicate with clients regarding study protocol or major statistical analysis issues. Represent clients with regulatory authorities. Interpret complicated analyses and write statistical sections of study reports. Provide mentorship to other biostatisticians in the department.
• Perform, advise, and review protocol development, sample size calculation, protocol and CRF review.
• Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and Data Management deliverables (i.e. database design, validation checks and critical data).
• Serve as primary contact as an expert in one or more therapeutic area including knowledge of therapeutic guidelines.
• Write publications.
• Advise on regulatory issues including integrated summaries of efficacy and safety, and liase with regulatory authorities on behalf of customer as required.
• Fulfill the Advisor/Lead role for a group of studies or integrated summaries. May fulfill the role of regulatory submission lead.
• Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for groups of studies.
• Lead the review of RFPs and QIPs, prepare proposal text and participate in bid defense meetings for regulatory submissions.
• Develop customer relationships.
• Provide training, guidance and mentorship to lower level and new staff.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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