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The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS.
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Familiarity with data management and visualization tools and collaborating with computational biology to analyze complex data sets emerging from clinical trials. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics/in vitro diagnostics, protocol design, and/or experience in development strategy preferred.
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The GRC plays an integral role towards our goal of developing extraordinary genetics and genomics research, focusing on finding the right targets and helping us better understand not only human disease biology but also the behavior of and response to our drugs in clinical trials.
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As a Clinical Research Nurse Practitioner (Sub-Investigator), you will play a key role in conducting clinical trials and ensuring their success by following Good Clinical Practices (GCPs) and the company's Standard Operating Procedures (SOPs.
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As part of the overall Clinical Trials Data Science team, this role will develop innovative and scalable analytical processes, lead statistical analyses, and conduct ad-hoc analyses that reflects and advances health care for a diverse patient population.
$111,000 - $188,700 a yearRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The GRC goal is to develop world class genetics and genomics research focused on finding the right therapeutic targets and helping scientists better understand not only human disease biology but also the behavior and response to our drugs in clinical trials across all therapeutic areas.
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Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access.
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Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report Form, Data Validation Plans, tables listings and figure (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to check the correct interpretation of the data)Under the supervision of an experienced statistician, may support more complex studies or asset level analyses (i.
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Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices. Strong statistical skills with application to clinical trials especially survival analysis methodology.
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The successful candidate will have the opportunity to work in a fast-paced and highly collaborative environment to contribute to oncology discovery and clinical development (including analysis of for analysis of high dimensional data from oncology clinical trials, real world evidence datasets to enable biomarker strategy, drug combinations, understanding of MOA, disease subtypes, indication selection, patient stratification, etc.
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Experience closely monitoring instrument/assay performance and/or clinical trials. Demonstrate skills and knowledge typically developed over a minimum of 6 years of product/assay/service development or clinical trial experience that includes at least 4 years’ project/team leadership.
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Provide scientifically rigorous statistical expertise on:Projects and protocols in support of clinical development and for publication, presentation, access negotiation, and other evidence generation efforts for Pfizer products; Regulatory and Health Technology Assessment (HTA) submissions; and projects to maximize the value of aggregate clinical and real world data in support of drug development and other scientific strategies.
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We're redefining the standard for care with world-class doctors and caregivers, innovative solutions, outstanding outcomes, and leading-edge research and clinical trials. Using evidence-based practice, clinical decision making, compassion and skilled dialogue, the registered nurse leads efforts to create the safest patient environment and the best patient experience.
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Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more.
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The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensuring AbbVie’s conformance to CDISC standards and industry best practices.
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clinical trials jobs in Bannockburn, IL
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