Clinical Trial Biostatistician

Responsibilities

• Statistical Programming & Validation
• Develop, program, and validate CDISC SDTM datasets from raw clinical data.
• Develop, program, and validate CDISC ADaM datasets to support planned analyses.
• Maintain end-to-end traceability between raw data, SDTM, ADaM, and TLF outputs.
• Perform independent QC and validation checks to ensure accuracy, completeness, and reproducibility.
• Metadata & Submission Documentation
• Create and maintain Define.XML for SDTM and ADaM deliverables.
• Prepare the Study Data Reviewer’s Guide (SDRG) for SDTM datasets.
• Prepare the Analysis Data Reviewer’s Guide (ADRG) for ADaM datasets.
• Produce annotated CRFs mapping collection fields to SDTM variables and controlled terminology where applicable.
• Statistical Analysis & Reporting
• Review protocol, SAP, SOPs, and study-specific procedures; provide written notification of review and understanding.
• Execute statistical analyses in full alignment with the approved SAP.
• Produce Tables, Listings, and Figures (TLFs) and contribute statistical output and narrative content for the Final Clinical Study Report (FCSR) for regulatory submission.
• Quality Assurance & Compliance
• Ensure all deliverables meet current FDA CDISC standards and related guidance (including define/guide conventions and annotation expectations).
• Produce documentation demonstrating CDISC compliance and audit readiness.
• Meet performance expectations, including a 95% compliance standard against deliverable requirements, on-time submission, and minimal need for substantive revision.
• Project Coordination & Communication
• Clock with WRAIR CTC staff on data transfers, review cycles, and issue resolution.
• Provide routine status updates on progress, risks, and dependencies; support inputs to the Program Management Plan (PMP) and Monthly Status Reports (MSRs).
• Communicate effectively with Government leaders, scientists, and stakeholders; clearly identify contractor status in all interactions.

Qualifications

• Master’s degree in Biostatistics, Statistics, or closely related quantitative field (or equivalent combination of education and experience).
• Demonstrated experience producing CDISC-compliant SDTM and ADaM datasets and associated metadata/documents.
• Strong statistical programming skills for clinical trials; SAS strongly preferred.
• Working knowledge of FDA submission expectations for study data standards and documentation (Define.XML, SDRG/ADRG, CRF annotation).
• Knowledge of GCP, ICH guidelines, and applicable 21 CFR requirements (including Parts 11, 50, 56, and 312).
• Proficiency with Microsoft Office (Outlook, Word, PowerPoint, Excel) and Adobe PDF tools.
• Strong written and verbal communication skills; able to operate effectively with Government stakeholders and cross-functional study teams.
• Able to work independently, manage shifting priorities, and deliver high-quality work on schedule in a deadline-driven environment.