Biostatistician

OverviewPlease 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.ResponsibilitiesEssential Job Functions:Perform statistical analyses in accordance with approved Statistical Analysis Plans (SAPs)Support development, review, and validation of CDISC-compliant deliverables, including:SDTM datasetsADaM datasetsDefine.xml documentationSDRG/ADRG documentationGenerate and validate Tables, Listings, and Figures (TLFs)Conduct data cleaning, quality control, and statistical validation activitiesSupport clinical study closeout and regulatory submission activitiesCoordinate with clinical research and project teams to support data review and analysis workflowsPrepare technical documentation and contribute to study reports and presentationsParticipate in project status meetings and provide progress updatesQualificationsNecessary 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 datasetsADaM datasetsDefine.xml documentationSDRG/ADRG documentationGenerate and validate Tables, Listings, and Figures (TLFs)Conduct data cleaning, quality control, and statistical validation activitiesSupport clinical study closeout and regulatory submission activitiesCoordinate with clinical research and project teams to support data review and analysis workflowsPrepare technical documentation and contribute to study reports and presentationsParticipate in project status meetings and provide progress updatesMinimum Qualifications:Master’s degree or higher in Biostatistics, Epidemiology, Statistics, Public Health, or related fieldExperience supporting clinical research or clinical trial studiesExperience developing or executing Statistical Analysis Plans (SAPs)Experience with statistical programming and analysis using SAS, R, STATA, or similar toolsExperience generating statistical outputs including Tables, Listings, and Figures (TLFs)Strong understanding of data validation, quality control, and analytical workflowsAbility to work independently and collaboratively in cross-functional scientific environmentsStrong written and verbal communication skillsAble to to successfully complete a background investigation and satisfy Government access requirements prior to beginning work.Preferred Qualifications:Experience supporting FDA-regulated clinical trialsHands-on experience with CDISC standards, including SDTM and ADaMExperience preparing Define.xml, SDRG, and ADRG documentationExperience supporting regulatory submission packagesPrior experience supporting Department of Defense (DoD), federal health, or military research organizationsFamiliarity with clinical data structures, including demographics, adverse events, laboratory, and longitudinal outcomes dataWork 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 ConsultantApproximately 10-Month Period of PerformancePay And BenefitsPay 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.