Job Description

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

We are seeking a qualified Biostatistician to provide statistical and clinical trial support for a Phase II clinical research effort supporting the Walter Reed Army Institute of Research (WRAIR). The selected candidate will support regulatory-focused statistical analysis activities, including CDISC-aligned deliverables and study closeout support associated with FDA submission requirements.

Responsibilities

Essential Job Functions:

• 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
• Coordinate 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:

• Demonstrate a functional understanding of the military milieu with a basic knowledge of DoD related terminology, structure, and operations and ability to effectively balance and resolve conflicts to mission execution
• Manage multiple and shifting areas of importance and have an ability to self-prioritize in a deadline-driven environment.
• Advanced expertise and experience managing and analyzing quantitative data using statistical software (SAS or SPSS).
• Demonstrate strong verbal and written communication skills.
• Possess excellent interpersonal and organizational skills.
• Work independently as well as collaboratively in a team
• Analyze complex and ambiguous situations, identify workable solutions and their potential outcomes, and make appropriate determinations based on regulations and policies.
• Interface effectively across the science and support community at large, as well as with representatives of sponsors, stakeholders, and other organizations.
• Communicate and coordinate with WRAIR personnel, program sponsor, and PI on policies, rules, regulations, and practices with respect to project administration and execution
• Knowledge of program evaluation practices, to include logic model development, formative and summative evaluation, program evaluation frameworks, and evaluation design, preferably in a public health context.

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
• Ability to work independently and collaboratively in cross-functional scientific environments
• Strong written and verbal communication skills
• Able to 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.
Position Type:

• Approximately 10-Month Period of Performance

Pay and Benefits

Pay for this position is $50.00 hourly.

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