Biostatistician

Goldbelt, Inc.•UNAVAILABLE, Maryland

4d•Hybrid

About The Position

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. 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.

Requirements

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.

Nice To Haves

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

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