Adverse Events, Background Investigation, Biostatistics, Building Systems, Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Research, Clinical Support, Clinical Trial, Communication Skills, Consulting, Cross-Functional, Data Analysis, Data Cleaning, Data Quality, Data Sets, Data Structures, Documentation, Epidemiology, FDA (Food and Drug Administration), FDA Requirements, Government Requirements, Health Information Technology, Healthcare, Hospital/Healthcare Construction, Medical Records, Military, Presentation/Verbal Skills, Public Health, Quality Control, R Programming Language, Regulations, Regulatory Submissions, Statistical Analysis System (SAS), Statistical Programming Languages, Statistical Quality Control, Statistics, Technical Writing, United States Department of Defense (DoD), Work From Home, Workflow Analysis, Writing Skills, XML (EXtensible Markup Language)
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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Goldbelt, Inc.
Goldbelt, Incorporated is an urban Alaska Native, for‐profit corporation headquartered in Juneau, Alaska. Incorporated on January 4, 1974 following the Alaska Native Claims Settlement Act (ANCSA), Goldbelt’s primary mission is to manage assets and conduct business for the benefit of its more than 3,600 shareholders. Goldbelt first ventured into the logging and timber industry but later expanded its operations into tourism, which still remains an integral part of its operations. Today, the majority of Goldbelt’s revenue and income derives from government contracting and services.
Goldbelt’s shareholder base consists of Alaska Natives who are of Tlingit and Haida descent. The Tlingit and Haida tribes are the indigenous people of Southeast Alaska, whose rich history spans more than ten thousand years in the region. Goldbelt shareholders own the entire 272,000 shares of Goldbelt stock, representing assets in excess of $100 million in addition to over 32,000 acres of land in the vicinity of Juneau. Goldbelt seeks to honor and preserve the Tlingit culture - its history, art, dance, legends, and the traditions of its Alaska Native shareholders. Learn more about Goldbelt Heritage.
The company is named after a richly mineralized zone in Southeast Alaska that encompasses 33,000 acres of Goldbelt’s land holdings— an area that stretches along the mainland from Frederick Sound to Berners Bay. Learn more about Goldbelt Lands.