RCRC Biostatistician III

publications. The successful candidate will independently execute and coordinate statistical activities for clinical and translational research studies while working under the scientific oversight of a faculty statistician. Serving as the primary day-to-day statistical resource for assigned studies, the individual will collaborate with investigators, sponsors, data managers, and regulatory experts throughout the research lifecycle. Responsibilities include: Supporting clinical and translational research studies from study design through reporting and publication. Collaborating with investigators, sponsors, clinical study managers, clinical data managers, and regulatory personnel throughout the research lifecycle. Performing statistical analyses and statistical programming using validated software and established methodologies. Contributing to protocol development, statistical analysis planning, sample size determination, and interpretation of study results. Preparing statistical outputs, reports, manuscripts, abstracts, presentations, and other scientific deliverables. Supporting regulatory submissions and ensuring compliance with applicable statistical, scientific, and regulatory standards. Contributing to continuous improvement initiatives and advancement of statistical best practices. Pursuing ongoing professional development and growth within the field of biostatistics. Essential Functions: Serves as the primary day-to-day statistical resource for assigned clinical and translational research studies while working under the scientific oversight of a faculty statistician. Independently develops and executes statistical analyses and statistical programming using validated software and established methodologies. Performs data review, quality checks, dataset preparation, and generation of statistical outputs to support study reporting and decision-making. Contributes to protocol development, statistical analysis planning discussions, sample size calculations, and interpretation of study results under the guidance of a faculty statistician. Assists in the preparation and review of protocols, statistical analysis plans, clinical study reports, manuscripts, grant applications, abstracts, and scientific presentations. Collaborate with investigators, clinical study managers, clinical data managers, regulatory personnel, and sponsors throughout the research lifecycle. Ensures statistical activities comply with applicable regulatory requirements, organizational standards, and best practices. Contributes to continuous improvement activities and shares knowledge with colleagues to support team effectiveness and organizational success. Actively pursues professional development opportunities through continued learning, knowledge sharing, participation in research activities, and engagement in teaching, mentoring, or methodological initiatives as appropriate. Minimum Education and Experience: Master's degree in the field of one of the following: Statistics, Biostatistics, Mathematics, Data Science, Biomedical, Health Sciences, or related quantitative field. Minimum 7 years relevant statistical clinical research experience within a regulatory agency (e.g., FDA ), in the pharmaceutical, biotechnology, or CRO industry. Alternatively, academic clinical research experience with some industry/ CRO experience. Two (2) years advanced knowledge of both analysis and dataset programming in at least one statistical programming language such as SAS or R is required. City: New Brunswick State: NJ Posting Number: 26ST1871