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Ph. D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 2 years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 4 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience.
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The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
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Experience with advanced knowledge of psychometrics, econometrics, and biometrics such as validation of health measurement scales, longitudinal data analysis, missing data methods, multiple comparisons techniques, cost-effectiveness analysis, generalized linear models, meta-analysis, real-world data analysis, and conjoint analysis.
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Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable.
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Solid understanding of clinical research methods, Clinical Data Interchange Standards Consortium (CDISC) principles, best data management practices and technologies related to clinical trials. The Director, Clinical Data Management (CDM), will provide data management support to clinical studies within the Biometrics function, and would be responsible for all CDM related areas/activities for clinical studies assigned.
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Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines. This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs.
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It is made up of outstanding professionals in functions related to clinical research, including but not limited to biometrics, clinical operations, clinical pharmacology, medical science, medical writing, project leadership, project management, and regulatory affairs.
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Robust clinical research experience within the pharmaceutical/biotech industry. Track record of successful and emerging research in therapeutic areas relevant to Intellia’s development programs and pipeline.
Starting at $250Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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5+ years of related experience, including 3 years of relevant industry experience, preferably in data services (data management and biometrics) or a clinical research environment. Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage.
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Acceptable: In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, biometrics clinical supervision, clinical study management, clinical monitoring, and clinical project management may be considered.
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As part of the Vertex Biostatistics Team, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may lead to medical breakthroughs.
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Solid understanding of drug development, clinical research, study design, and CRO oversight. Reporting to the Head of Biometrics, a successful candidate will be able to operate independently and thrives in a fast-paced environment.
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Aware, a global leader in biometrics, is seeking a Customer Technical Support Engineer reporting directly to the Senior Director of Research. Diagnose and troubleshoot technical issues, involving detailed analysis and collaboration with the research and development team when necessary.
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Experience of independent academic research and/or clinical drug development including knowledge of statistical methodology use in the design and analysis or early and late Phase clinical trials.
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