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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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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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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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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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Work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, Biometrics, and Clinical Operations. As a Clinical Research Physician , you will provide clinical mentorship and scientific leadership for clinical development programs within AstraZeneca's global organization.
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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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Support the selection of biometrics vendors. This role reports to the Head of Biometrics. Participate in data review along with biostatistics and statistical programming team. Responsible for reviewing the data management documentation, data management plan (DMP), CRF, study database specifications, data validation plan, edit check specifications, data transfer specifications, data issue logs, data review plans and ensures all documents follow study design and regulatory requirements.
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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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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.
RemoteExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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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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This position is primarily remote, non-office based, with the expectation to travel up to 50%. Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process.
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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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biometrics research jobs in Boston, MA
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