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.

More here.

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