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As a Research Associate, Molecular Biology, you will report to the Principal Scientist - Cell Characterization to perform the collection and quality control analysis of cell samples for genomic and epigenomic assays, as part of Sana's Cambridge Stem Cell Sciences group.
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Experience with pharmaceutical data sources (e.g., IQVIA or Symphony claims, specialty pharmacy data, and Syndicated data sources); Deep understanding across various pharmaceutical data facets/processes, including data creation and acquisition, management, governance, data quality, integration, visualization and statistical modelling.
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As a member of the T1D Exchange Quality Improvement and Population Health Team, you will join an innovative team of experts using big data and predictive analytics to advance diabetes care. The candidate will design and implement statistical analyses for quantitative, qualitative, survey, and interventional research, as well as to help establish best practices for data analytic strategies and population health projects.
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The Health Policy & Equity section research combines the use of real-world data with advanced statistical, econometric, and epidemiological methods to answer questions related to healthcare access, quality and value, and population health, with a focus on cardiovascular outcomes.
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Research has centered on drug delivery, intravascular imaging, antithrombotic therapy, renal denervation, and pulmonary embolism intervention, with an emphasis on the use of novel statistical methods and the use of risk prediction models to guide treatment.
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Utilizes standard statistical packages (e.g., SAS, R, Stata, SPSS) and other project-specific software. Ability to ensure compliance with data governance and data quality processes and procedures.
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Apply and instruct others in the use of Quality systems (CAPAs, change control, measurement systems and Analysis (MSA), Statistical Analysis, Control Plans, document management, etc) Includes the use of various statistical techniques and quality tools.
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Network with manufacturing and quality organizations internal to Amgen. Statistical analysis, and knowledge of Gage R&R, Useful to have exposure to test method development, CAD design, Solidworks, mechanical modeling.
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Design/develop relational database, including management of data for clinical research including clinical trials, health services research, survey studies, qualitative research, and quality improvement projects.
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Experience with statistical data analysis using R or JMP, monitoring data quality and troubleshooting technical problems. Analyze workflows, identify bottlenecks, develop solutions and lead teams in solution implementation that improves efficiency, throughput, cost, and quality.
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Review manufacturing, quality, engineering SOPs, FMEAs, process validations (MVP, CSV, IQ, OQ, PQ) through document control system for conformance to applicable regulations and business needs. Provides engineering guidance and execution of deliverables for incoming inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Under the guidance of the CRD he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical review, as needed.
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Responsibilities Experienced in facilitating Quality risk assessments Good technical writer and write the documents that support the risk assessment Participate in Risk Assessment activities, applying Phase appropriate guidance for engineering deliverables for production support leading and owning risk assessments in support of change controls and deviations.
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Contribute to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved some of the study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to Pharmacovigilance or safety events of special interest.
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Reporting to the Lead of Clinical Data Programming, Data Management, the clinical programmer works in varied therapeutic areas, develops and validates SAS/SQL programs and macros, performs data and programming quality checks, generates validation documentation, performs data reconciliation/integration, and liaises with internal teams/external vendor/partners to resolve issues.
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quality statistical jobs in Boston, MA
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