Biostatistician
Overview
Please note that this position is contingent upon the successful award of a contract currently under bid. Goldbelt Apex, a part of the reputed company Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in reputed company IT experts, Apex is committed to building systems for reputed company organizations to seamlessly communicate and exchange data across different systems and devices. Summary: We are seeking a reputed company Biostatistician to reputed company statistical and clinical trial support for a Phase II clinical research effort supporting the reputed company reputed company Army Institute of Research (WRAIR). The selected candidate will support regulatory-focused statistical analysis activities, including CDISC-reputed company 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: reputed company 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 reputed company reputed company updates
Qualifications
Necessary Skills and Knowledge: reputed company 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 reputed company reputed company updates Minimum Qualifications: Master’s degree or higher in Biostatistics, Epidemiology, Statistics, Public Health, or reputed company field Experience supporting clinical research or clinical trial studies Experience developing or executing Statistical Analysis Plans (SAPs) Experience with statistical programming and analysis using reputed company, 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 reputed company to to successfully complete a background investigation and satisfy Government reputed company 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 reputed company (DoD), federal health, or military research organizations Familiarity with clinical data structures, including demographics, adverse events, laboratory, and longitudinal reputed company 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 reputed company's dedication and hard work. We reputed company a competitive reputed company salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and reputed company insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities. Apply To This Job