Clinical Trial Biostatistician

Biostatistician

The Biostatistician will provide statistical and statistical-programming support for a Phase 2a randomized, double-blind clinical trial evaluating a hantavirus vaccine for the prevention of Hemorrhagic Fever with Renal Syndrome (WRAIR 2725). The Biostatistician will develop FDA-ready, CDISC-compliant deliverables, execute analyses per the approved Statistical Analysis Plan (SAP), and support generation of regulatory-submission outputs required for FDA filing and study close-out.

This is a fractional, deliverable-driven role with workload concentrated around dataset development, validation, and analysis milestones. Work supports Force Health Protection research and directly enables WRAIR's regulatory submission.

Compensation & Benefits:

Estimated Starting Salary Range: TBD

Pay commensurate with experience.

Full time benefits include Medical, Dental, Vision, 401K and other possible benefits as provided. Benefits are subject to change with or without notice.

Clinical Biostatistician

Responsibilities Include:

Statistical Programming & Validation

• Develop, program, and validate CDISC SDTM datasets from raw clinical data (e.g., demographics, adverse events, labs, vitals, concomitant medications).
• 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

• Coordinate 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.

Indicative Deliverable Timeline (from study review start)

• SDTM + ADaM datasets, Define.
  
  XML, SDRG, ADRG, annotated CRF: within 3 months
• Statistical analyses completed: within 8 months
• FCSR statistical deliverables completed: within 11 months

Clinical Biostatistician Experience, Education, Skills, Abilities requested:

Required 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.
• Ability to work independently, manage shifting priorities, and deliver high-quality work on schedule in a deadline-driven environment.

Preferred Qualifications

• PhD in Biostatistics or Statistics.
• Experience supporting vaccine, infectious disease, and/or Phase 2 clinical trials.
• Prior experience preparing statistical content for FDA regulatory submissions and clinical study reports.
• Familiarity with DoD/military medical research environments and terminology.

Minimum Security Level:

• Favorable Tier 1 NACI (or equivalent/higher) completed prior to start, or an open/pending investigation with no unfavorable information, as allowed by the customer.
• Ability to obtain and maintain a Common Access Card (CAC) for on-site facility and network access.
• Must be able to complete a National Agency Check and obtain installation access at WRAIR.
• Must pass…