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Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine and development operations.
$161,600 - $269,400 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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BASIC QUALIFICATIONS Ph. D. in biostatistics or related discipline with 7+ years of experience with patient-reported outcomes, health economics, health technology assessment, and outcomes research methodology used in clinical trials and observational studies.
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Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology. Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators.
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The Center for Immunobiology, Center for Clinical Research, WMed ForenTox, Research Histology Lab, Innovation Center, Division of Epidemiology and Biostatistics, and Human Research Protection Program contribute to the medical schools advancement of knowledge through innovation and discovery.
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MINIMUM JOB REQUIREMENTS BA/BS in life sciences or equivalent; or RN/BSN. Advanced degree or certification preferredAt least 6 – 8 years of clinical research experience, with a minimum of 4 years having effectively led a project from inception to completion coupled with demonstrated ability to hold team members accountable with minimal oversight.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Master's Degree in a quantitative discipline such as Epidemiology, Biostatistics, Economics, Statistics, Clinical Informatics, Mathematics, Data Science, Data Analysis and/or related fields.
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. Position Overview: As a Principal Statistical Programmer with a specialized focus on PK/PD, you will play a pivotal role in the design, execution, and analysis of clinical trials to support the development of our promising drug candidates.
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Master's or Ph. D. in Biostatistics, Statistics, or a related field with a strong emphasis on pharmacokinetics (PK) and pharmacodynamics (PD) tables within tight timelines. Leveraging your extensive knowledge of statistical programming and PK/PD principles, you will collaborate closely with cross-functional teams of scientists, clinical researchers, and biostatisticians to ensure the successful implementation of our clinical development programs.
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The School has extensive collaborations with the School of Medicine, Moores Cancer Center, Jacobs School of Engineering, Scripps Institution of Oceanography, Altman Clinical and Translational Research Institute, Rady School of Management, Skaggs School of Pharmacy, and with other partners across the UC San Diego campus.
$86,500 - $297,200 a yearExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Clinical research experience,knowledge of biostatistics, clinical trial design, grant writing and research ethics is e. To promote the development of clinician researchers, while supporting the growth of biomedical research within Lincoln Medical Center, the Fellow will contribute to a 2-year prospective, longitudinal evaluation of medical resource utilization and predictive measures of short- and long-term outcomes following acute COVID-19 infection, including evaluation of physical and mental health outcomes - as well as the social determinants of health - among a cohort of patients living in the South Bronx.
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Provide matrix leadership to the multi-functional development team including toxicology, biostatistics, clinical research consultants, quality, CMC, PK and Medical. Integrate data from multiple scientific disciplines across the project (e.g., biology, chemistry SAR, pharmacokinetics and ADME, statistics, experimental medicine, and clinical study design) to derive plans and in interpreting outcomes.
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Oversees a diverse and highly skilled group of experts in clinical medicine, epidemiology, biostatistics, public policy, and data management and analysis, including Directors, Associate Directors and Technical Leads.
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Collaboration is key and the research milieu within the institute offers access to other IU faculty scientists who have a wealth of interdisciplinary research expertise including health services research, clinical practice, medical sociology, computer science, medical informatics, medical outcomes, public health and epidemiology, engineering, biostatistics, and implementation science.
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Relevant areas include bioinformatics, translational bioinformatics, clinical informatics, clinical research informatics, consumer health informatics, and public health informatics.
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Head up the development team starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
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