Notice ID: 75N95024Q00149_SB
The Contractor shall provide biostatistics consulting services to the National Institute of Neurological Disorders and Stroke (NINDS) CTU as follows:
- Provide expert and strategic statistical technical support, guidance, education, and advice on advancing NINDS projects through nonclinical and clinical development.
- Perform complex statistical analyses, prepare and review statistical analysis plans, provide detailed specifications for electronic analysis files, and quality check statistical analyses including tables and figures.
- Communicate with Government staff and investigators regarding statistical protocol design and data analysis issues.
- Evaluate the design of NINDS’ proposed studies and milestones using sound statistical analysis methodology to ensure studies are sufficiently powered and controlled with experimental and statistical rigor that will lend a high degree of confidence in study results.
- Interpret and, as needed, perform biostatistical/statistical analyses of datasets.
- Assist in the writing of statistical sections of study reports.
- Explain statistics in plain language, and participate in educational activities upon request.
- Provide verbal and written feedback and technical recommendations regarding biostatistical data relating to NINDS projects.
- Provide technical review and feedback on statistical data to inform project milestones, progress reports, development plans, study design, database design, and data interpretation.
- Communicate with Government staff and clinical trial investigators to facilitate discussions to support the NINDS’ research strategy.
- Provide written guidance to Government staff and clinical trial investigators on the appropriate statistical methods to employ to accurately interpret clinical trial results.
- Assist NINDS CTU staff in preparing investigational and research study protocols.
