Job Description
Title: Biostatistician
Location: Maryland, United States
Healthcare
Goldbelt Apex, LLC
Public Trust
19655
RFP
Overview
Please note that this position is contingent upon the successful award of a contract currently under bid.
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.
This is a part-time consulting opportunity anticipated to run for approximately 10 months.
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:
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
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:
Part-Time Consultant
Approximately 10-Month Period of Performance
Pay and Benefits
Pay for this position is $50.00 hourly.
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
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