Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health, and Information Technology to both private industry and government agency clients. TRI is currently seeking a Director, Biostatistics/Data Management to join our Bethesda, MD team.
• Oversee data collection, programming, analysis, and reporting activities for Phase I-IV clinical studies, integrated databases and analyses, safety reviews and ad-hoc analyses
• Supervise Statistical, Data Programming, and Data Management staff, with all incumbent supervisory responsibilities
• Establish staff competency requirements and training programs
• Mentor staff and aid in their development and achievement of competency standards
• Standardize, improve, and develop SOPs for database development, data management, analysis, and reporting processes.
• Prepare statistical analysis plans for a single project and for an integrated summary of safety (ISS) and an integrated summary of efficacy, and review and approve case report form design, data management plans, and edit specifications
• Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate shell data displays, perform validation and quality control of complex data displays, write statistical reports and statistical section of clinical study reports
• Support project teams on achieving client satisfaction through delivery of quality data, on-time and on-budget
• Ensure revenue and operating margin performance of the data management group to agreed targets
• Review literature and research technologies/procedures for improving statistics, programming, and EDC practices
• Support business development and marketing activities at client presentations and professional seminars
• Participate in proposal development and defense processes
• Establish and maintain strategic client relationships
• Ph.D. in statistics or related discipline with 8+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management (2+ years), and expertise in one or more therapeutic areas.
• 5 years’ experience as a project manager
• Broad knowledge and superior understanding of advanced statistical concepts and techniques.
• Advanced SAS programming knowledge and proficiency with other statistical packages and sample size calculation software
• Familiarity with EDC systems
• Expert knowledge of clinical data standards and data flows as well as industry standards for submission of data
• Good knowledge of Oracle databases
• Experience in web-based systems development
• Experience overseeing projects that include safety, regulatory, and site operation components, in addition to data management and biostatistics
• Client management experience
• Excellent oral and written English and good presentation skills
• Knowledge of the drug development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical and medical device business.
• Proven ability to plan and manage capital and operating budgets, as well as plan and advocate staffing resources
Submit resume with salary requirements to Attn: MH, TRI, 6500 Rock Spring Dr., Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to email@example.com.
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing, and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.