Head of Strategic Biostatistics

Location: Research Triangle Park, NC Job Category: Biotech/R&D/Science Career Level: Executive (SVP, VP, Department Head, etc) Quintiles Transnational is the market leader in providing research, sales and marketing, healthcare policy consulting, and health information management services to the healthcare industry. Quintiles has more than 20,000 employees worldwide and offices in over 50 countries. We are currently seeking a Head of Strategic Biostatistics. The location of this position is negotiable. The Head of Strategic Biostatistics will provide co-ordination world-wide for the Strategic Biostatistics Unit, and manage this function for a large region or on a worldwide basis. One large responsibility of this position is to ensure, on a global basis, that maximal use is made of Quintiles Strategic Biostatistics expertise to win new fullscope high value business. In this position, you will provide strategic biostatistical (and general drug development) input, to high priority sales opportunities to help increase revenue for Product Development, with emphasis on methods to cut costs, decrease time, or increase chance of success for drugs under development by biotech clients and certain mid-size pharmaceutical companies. The Head of Strategic Biostats will also provide strategic biostatistical (and general drug development) input at the program-wide level for one or more pharma companies with whom Quintiles has entered into a partnership, with key focus on those very large programs, for which strategic biostatistical input aims to help win further high value business, or help retain existing business. May also provide training for partner companies. Co-ordinate Biostatistics support on all matters related to Due Diligence or Alliance Management and provide strategic biostatistical input to the Due Diligence assessment of compounds in which a large investment is being considered. The Head of Strategic Bios will provide strategic biostatistical support to increase revenue & operating income by increasing chance of approval (or decreasing time to approval) for compounds in which the Company has already made a large investment. The position will also carry out developments in areas of statistical design or analysis that can be used to give Quintiles a greater edge over competitors, and ultimately help to win more high value business. Provide training to others in the group to enable them to give strategic biostatistical input to sponsors and potential sponsors. Represent clients at FDA or EMEA meetings, FDA advisory committee meetings, or meetings with other regulatory authorities. PhD or educational equivalent in biostatistics or related field 12 years relevant experience including 10 years of senior management experience Extensive and in-depth knowledge of most of those complex statistical analysis methods that apply to Phase II-IIIB clinical trials, which can be used to cut time, cut costs, and/or increase chance of success Extensive and in-depth knowledge of most of the new and cutting-edge design approaches (including many types of adaptive designs) that can beneficially be applied to Phase II-IIIB clinical trials Demonstrated ability to develop new (design and analysis) methods to cut costs, decrease time, or increase chance of success for drugs under development High level of knowledge of current FDA and EMEA regulatory requirements with respect to clinical development programs, study designs, primary endpoints, and acceptable analyses for multiple therapeutic areas Comprehensive understanding of the clinical drug development process High level knowledge of SAS