Manager/Director, Biostatistics #293472

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. Manager/Director, Biostatistics North Wales, PA and Raleigh, NC 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. Responsibilities also include assigning projects to biostatisticians within the local office and monitoring staff utilization. Adjusts workloads when needed and monitors progress on biostatistics projects within the local office. Assists staff members with the identification of out-of-scope work and, when necessary, works with Business Development Associates to secure additional project funding. Recruits, hires and trains new biostatisticians for the local office. Conducts performance reviews. Collaborates with Biostatistics Departments in other locations within ICON to develop and maintain standard operating procedures (SOPs) and study specific procedures (SSPs). Ensures that biostatisticians within the local office operate according the SOPs and SSPs. Prepares and approves research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients in the pharmaceutical, biotechnology, computer, and manufacturing industries. As needed, participates in proposal defense meetings and makes presentations at marketing meetings with prospective clients. Documents all work to ensure an adequate audit trail and reproducibility. Participates in the setting of document standards. Functions as a Senior Biostatistician, Project Director on projects as needed. Performs additional duties as assigned. The qualified candidate will have six to eight years of industry experience, a Master's or PhD in Biostatistics or a related discipline, a record of successful management, and outstanding communication skills. A history of direct and successful interaction with FDA and EMEA is preferred. **The level of position will be dependant on the experience level of the candidate** 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 or you can email your resume directly to william.vannewkirk@iconplc.com No agencies, please. ICON. A Symbol of Excellence. ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity. To Apply for this position, please CLICK HERE