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Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications. Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
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Manage assigned R&D Quality Risk Management activities - assessment of QC of clinical trials execution in a GCP regulated environment. Work closely with internal R&D teams and Contract Service Providers as clinical trials are designed and conducted.
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We are seeking an Epic Research Analyst that is well versed in the academic research environment, and familiar with clinical trials workflows and holds the following Epic Certifications: Research Billing and Research Clincal.
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7 years' minimum experience of management experience leading Biostatistics and programming supporting clinical trials. As the first hire for their Biometrics team, you will be responsible for the growth of the team, including, Statisticians, Programmers and Clinical Data Management.
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Responsible for coordinating and managing clinical trials including providing all aspects of protocol implementation, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen collection and submission, and maintenance of accurate and complete clinical research files.
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