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Leidos is currently seeking a Senior Biostatistician to support the Biomedical Advanced Research and Development Authority (BARDA) within HHS in Washington DC. Be the lead biostatistician to help find correlates of protection for BARDA’s work on Project NextGen to develop the next generation of COVID vaccines. Work with a dedicated team of scientists and researchers to support vaccine and therapeutic development as part of a White House priority effort.

Responsibilities Include:

• Serve as a subject matter expert to provide technical advice to project coordination team for vaccine and therapeutic candidates in phase 2-3 clinical studies
• Assist with the development of statistical analysis plans, including sampling plans for markers/assays for a range of candidate vaccines
• Conduct correlates of protection analysis
• Develop study reports, including preparation for publication in peer-reviewed journals.
• Consult and collaborate with other scientists on clinical trial development and execution, data analysis, and interpretation of study results
• Evaluate data quality and Clinical Data Interchange Standards Consortium (CDISC) compliance.
• Produce/validate statistical analyses and outputs for clinical studies
• Prepare data transfer agreements and coordinate data transfer activities.  
• Review and study clinical trial data

Required Qualifications, Skills, and Education:

• MS in biostatistics, statistics, mathematics, epidemiology, or other closely related discipline with 6 or more years of relevant experience
• Strong background in biostatistics and clinical trial analysis
• Extensive experience with vaccine development, including phase 2/3 trials and interacting with FDA
• Proven experience with determining vaccine efficacy, immunogenicity, and correlates of protection
• Proven abilities with scientific or mathematical software or programming; particularly R or other statistical language
• Excellent communication skills with the ability to successfully interact with a diverse group of senior scientists and other stakeholders
• US Citizen; Currently possess or ability to successfully obtain/maintain a public trust clearance

Preferred Qualifications, Skills, and Education:

• Subject matter knowledge of quantitative infectious disease modeling, COVID-19 epidemiology, and/or related sciences
• Experience working with a data-science team, including knowledge of best practices of code management and working with large-scale data
• Experience overseeing / collaborating with statistical trials led by other groups

EIO 2024