Director, Biostatistics job in Bethesda at Technical Resources International
Technical Resources International

Job Info

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Responsibilities:

• 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

Recommended Skills

• Clinical Study Reports
• Drug Development
• Clinical Trials
• Analysis
• Presentations
• Research

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