Director - Sr. Director, Biostatistics, PS # 293325

We work together to find a better way and break new ground to make progress possible. Focused on common goals, we raise the standard and make a difference. We strive for excellence in everything we do. At ICON, career possibilities can become realities for those who look for challenges and embrace learning and growth opportunities. ICON Clinical Research is dedicated to providing the pharmaceutical and biotechnology industries with exceptional clinical research and biometrics services. Join us in one of our current openings and enjoy highly competitive benefits and exceptional advantages. The selected candidate for this position will be responsible for overseeing statistical input to study design, analysis, and reporting. Will direct collaboration with medical scientists in the design of clinical studies and the development of study protocols and ensure that appropriate analysis procedures are used and that study reports accurately describe statistical methods and results of analyses. Will also oversee statistical activities that support the company's interactions with clients and regulatory agencies and provide input on statistical issues relating to client regulatory submissions. Will respond to statistical questions raised by regulatory agencies and assist clients with statistical aspects of regulatory agency negotiations. Reviews and approves statistical methods sections of study protocols, statistical analysis plans, statistical analyses, and statistical input to reports. Will ensure that Biostatistics Department projects within the local office are conducted within budget and in a timely and quality manner. Reviews and approves timesheets for direct reports as well as project time reports for biostatistics projects conducted in the local office. Conducts regular departmental meetings and organizes and conducts interdepartmental project review meetings designed to coordinate data management, biostatistics, statistical programming, quality assurance, medical writing, and business development resource allocation and timelines. QUALIFICATIONS/EXPERIENCE REQUIRED: Ph.D. in statistics, biostatistics, or related field with at least 10 years of experience (at least 8 of which must be in statistical applications in the pharmaceutical industry); or M.S. degree in statistics, biostatistics, or related field with at least 12 years experience (at least 10 of which must be in statistical applications in the pharmaceutical industry). History of increasing management responsibility, including at least 2 years experience as a Project Director and at least 2 years experience as an Associate Director. Knowledge of a wide variety of principles, theories, and concepts in statistics and experimental design. Must be able to apply knowledge to the design and analysis of clinical trials. Comprehensive knowledge of clinical trial methodology, regulatory requirements, statistics, and statistical soft Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive benefits in addition to flexible scheduling, relocation assistance, tuition reimbursement, credit union, health club privileges, and many other exceptional advantages. TO APPLY and for more information on our opportunities and locations, please visit us at http://www.iconclinical.com/index.asp?getpage=true&sid=10 . No agencies, please. ICON. A Symbol of Excellence. ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity. www.iconclinical.com