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Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review and address comments by IRB/ECs.
$216,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Collaborative Health Studies Coordinating Center (CHSCC) in the Department of Biostatistics is seeking a full-time data analyst/statistical programmer to join our collaborative research team.
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Under the direction of Dr. Shaban-Nejad, the Postdoctoral Fellow will be responsible for Cancer data analytics, statistical modeling, developing machine learning algorithms and models, geocoding, and visualization of the proposed framework.
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Works collaboratively with vendors, Clinical Research, Drug Safety, Regulatory Affairs, Clinical Operation, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting.
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Collaborates with Clinical Operations, Data Management, Clinical Development, Drug Safety, Statistical Programming, and Biostatistics to develop standard and custom data reports for quality data oversight / clinical data review.
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The Department of Epidemiology & Biostatistics at the University of California, Irvine, is searching for multiple postdoctoral scholars to work on the precision medicine and NIH brain mapping project.
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The placement of Biostatistics in the Perelman School of Medicine with world-class medical, biological, and population scientists, as part of an integrated campus including the Wharton School of Business, School of Arts and Sciences, and the School of Engineering and Applied Science and other premier biomedical research institutions including the Children's Hospital of Philadelphia provides the ideal setting for cross-disciplinary collaboration and impactful quantitative research.
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Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
$148,000 - $194,250 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
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Masters Degree in Statistics (or Biostatistics) and 3+ years of experience as a statistician in academia, biopharmaceutical, or diagnostics industry, academia, or FDA; OR, PhD in Statistics (or Biostatistics) and 1+ year(s) of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, academia, or FDA.
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Strong study design and statistical analysis skills with proficiency in one are more statistical applications (SAS/R/Python) is required. PhD preferred, minimum MS in Statistics/Biostatistics, Health Economics, Epidemiology required.
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Firmly grounded in the scientific fundamentals of one or more of the core HEOR specialties (epidemiology, biostatistics, patient reported outcomes, health services research, economics, clinical practice or behavioral science.
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Caris Life Sciences is looking for a sharp, driven and goal oriented Bioinformatics Scientist to support our bioinformatics and statistical analysis leadership as well as novel biomarker discovery derived from Caris proprietary ADAPT Biotargeting SystemTM. These critical roles will work closely with our Bioinformatics & R&D teams to assist in designing experiments, analyzing complex clinical and translational data sets.
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Conducts research gap analysis, drafts / revises protocol synopsis, develops statistical analysis plan for real-world evidence and other outcomes research studies. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
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Apply statistical (descriptive, analytical, inferential) analysis and data mining techniques to generate real-world evidence and prediction systems for stand-alone projects or to be assimilated into production systems.
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