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Senior Biostatistician

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Raleigh, NC

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Senior Biostatistician BASIC SUMMARY: Develop and implement statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Participate in the project specific programming of statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs). May be responsible for administrative supervision of interns. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Coordinate statistical reporting activities for multiple projects simultaneously. * Develop and review statistical analysis plans based on study specific documents and sound statistical methodology. * Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, tables, listings, and figures. * Ensure the efficiency, quality, and integrity of data reporting, project and supervisory activities executed. * Actively monitor project budgets and help staff identify resourcing or scope of work changes. * Provide accurate and timely status updates to other team members, colleagues, and senior management. * Successfully represent department and company in a multi-disciplinary setting, such as project teams, project meetings, and client meetings/presentations. Maintain a positive working relationship with clients. * Interact collaboratively with other departmental staff to ensure that project and department activities are successfully completed. * Advocate the departmental team approach for effective management of broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. * Assist in the interview and selection of qualified personnel. * Assist in the development, implementation, and delivery of departmental training programs. * Assist in providing regular coaching and counseling. * Assist in the development, maintenance, and communication of departmental systems and SOPs. * May provide direct daily supervision of limited assigned departmental employees. If applicable, review work of direct reports to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures; identify training and development needs of direct reports; ensure that any direct reports receive departmental orientation and necessary on-the-job training; assist in preparation and delivery of performance reviews of direct reports. * Perform all other related duties as assigned. About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffingu00ae Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please **** or email **** for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

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