Specific Duties & Responsibilities

• These are the specific duties and responsibilities, but not limited to, based on the stage of a clinical research trial/study.
• Provide statistical considerations into study protocols.
• Perform sample size and power calculations, generates randomization schema, and prepares statistical sections for research protocols and manuscripts.
• Collaborate with principal investigators and lead statisticians to develop study objectives, randomization, design sampling, and statistical analysis plans (SAPs)
• Review and provide feedback on electronic case report forms (eCRFs) to the data management team.
• Create and review analysis dataset specifications for Data and Safety Monitoring Board (DSMB) meetings and main trial manuscript as outlined in the SAP.
• Generate Tables, Listings, and Figures (TLFs) for Data and Safety Monitoring Reports.
• Create and manage Data and Safety Monitoring Report production timelines.
• Create safety surveillance report templates: listings of adverse events and protocol deviations.
• Provide statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications.
• Perform appropriate methodologic procedures for statistical analysis, overall descriptive statistics, exploratory data analyses, including graphs, schematic summaries, and necessary transformations and confirmatory data analyses, including statistical tests and/or modeling.
• Assist with writing statistical design, methods, and analysis for manuscripts and research proposals.
• Analyze data and prepare tables for interim and final reports.
• Participates in regularly scheduled meetings with investigators and team that require statistical input.
• Ensure data integrity and compliance with security policies governed by HIPAA and the Johns Hopkins IRB.
• Any other responsibility/task deemed within the scope of the statistical duties by the leadership.