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 statistical programming, analysis, and reporting activities for Phase I-IV clinical studies, integrated databases and analyses, safety reviews and ad-hoc analyses
- Supervise Statistical and Data Programming 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 data analysis and reporting processes.
- Prepare statistical analysis plans for single projects, integrated summaries of safety, and integrated summaries of efficacy
- 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 and programming 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 15+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management (5+ years), and expertise in one or more therapeutic areas.
- 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
- 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
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.