Biostatistician

Responsibilities

• Perform statistical analyses in accordance with approved Statistical Analysis Plans (SAPs)
• Support development, review, and validation of CDISC-compliant deliverables, including:
• SDTM datasets
• ADaM datasets
• Define.xml documentation
• SDRG/ADRG documentation
• Generate and validate Tables, Listings, and Figures (TLFs)
• Conduct data cleaning, quality control, and statistical validation activities
• Support clinical study closeout and regulatory submission activities
• Cook up with clinical research and project teams to support data review and analysis workflows
• Prepare technical documentation and contribute to study reports and presentations
• Participate in project status meetings and provide progress updates

Qualifications

• Necessary Skills and Knowledge:
• Perform statistical analyses in accordance with approved Statistical Analysis Plans (SAPs)
• Support development, review, and validation of CDISC-compliant deliverables, including:
• SDTM datasets
• ADaM datasets
• Define.xml documentation
• SDRG/ADRG documentation
• Generate and validate Tables, Listings, and Figures (TLFs)
• Conduct data cleaning, quality control, and statistical validation activities
• Support clinical study closeout and regulatory submission activities
• Cook up with clinical research and project teams to support data review and analysis workflows
• Prepare technical documentation and contribute to study reports and presentations
• Participate in project status meetings and provide progress updates
• Minimum Qualifications:
• Master’s degree or higher in Biostatistics, Epidemiology, Statistics, Public Health, or related field
• Experience supporting clinical research or clinical trial studies
• Experience developing or executing Statistical Analysis Plans (SAPs)
• Experience with statistical programming and analysis using SAS, R, STATA, or similar tools
• Experience generating statistical outputs including Tables, Listings, and Figures (TLFs)
• Strong understanding of data validation, quality control, and analytical workflows
• Able to work independently and collaboratively in cross-functional scientific environments
• Strong written and verbal communication skills
• Able to successfully complete a background investigation and satisfy Government access requirements prior to beginning work
• Preferred Qualifications:
• Experience supporting FDA-regulated clinical trials
• Hands-on experience with CDISC standards, including SDTM and ADaM
• Experience preparing Define.xml, SDRG, and ADRG documentation
• Experience supporting regulatory submission packages
• Prior experience supporting Department of Defense (DoD), federal health, or military research organizations
• Familiarity with clinical data structures, including demographics, adverse events, laboratory, and longitudinal outcomes data

Work Location

Primary support is associated with WRAIR in Silver Spring, MD. Remote work may be permitted, subject to task requirements and Government approval.

Pay And Benefits

Pay for this position is $50.00 hourly.