Biostatistician
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Responsibilities Design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D Develop statistical analysis plans (SAPs) and perform statistical analyses using SAS, MATLAB, and R Provide statistical input for study protocols, case report forms (CRFs), and clinical study reports (CSRs) Ensure statistical deliverables meet regulatory requirements and industry standards (FDA, EMA, ICH-GCP, ISO) Provide data summaries to support data integrity and data review during ongoing studies Support regulatory submissions with statistical summaries and responses to agency queries Contribute to scientific publications and presentations of clinical data Stay current with statistical methodologies and regulatory guidelines relevant to medical devices and diabetes research. Performs other duties as required. Requirements Bachelor's in Biostatistics, Statistics, or a related field Minimum of 5 years of experience in biostatistics within the medical device or pharmaceutical industry Proficiency in statistical tools, such as SAS, MATLAB, and R for programming and data analysis Strong understanding of clinical trial design, data management, and regulatory requirements #J-18808-Ljbffr Jobtailor
Vacancy posted 3 days ago
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