Goldbelt, Inc. logo
Goldbelt, Inc.

Goldbelt, Inc. is a facilities services company that is “building a brighter future” for its Alaska Native shareholders. The company, as an employer, strive

Biostatistician

Location

Maryland

Posted

8 days ago

Salary

$50 / hour

Seniority

Mid Level

No structured requirement data.

Job Description

Biostatistician

Goldbelt, Inc.

Role Description 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 - 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 - 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 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 - Comprehensive benefits package, including: - Medical, dental, and vision insurance - 401(k) plan with company matching - Tax-deferred savings options - Supplementary benefits - Paid time off - Professional development opportunities

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