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Collaborates with Data Management, Clinical Development, Clinical Operations, Drug Safety, Statistical Programming, and Biostatistics to develop standard and custom data reports for quality data oversight / clinical data review.
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Associate Director, Biostatistics - Virology. The Associate Director will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products at Gilead.
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PhD in Statistics, Biostatistics, or Mathematics with at least 7 years in the clinical development setting in pharmaceutical or biotechnology industry, or Master's degree in related discipline with a minimum of 12 years' relevant experience.
$195,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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Daily activities will include, but are not limited to, working within a team environment and leading functional internal audits of VO's electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO's documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
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Work closely with GxP Quality Assurance and functional areas responsible for the conduct of clinical research (e.g., Clinical Operations, Clinical Development, Biostatistics and Data Management, Pharmacovigilance, etc.
$155,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.
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Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases.
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Minimum Education & Experience PhD in biostatistics or related discipline with 2+ years’ relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry or a related environment.
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Ph. D. in Computational Biology, Biostatistics, Statistics, Bioinformatics or related field. At least five years of experience collaborating as a computational biologist or biostatistician is desirable.
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Collaborates with Clinical Operations, Data Management, Clinical Development, Drug Safety, Statistical Programming, and Biostatistics to develop standard and custom data reports for quality data oversight / clinical data review.
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Master’s degree (e.g. MA, MSc, MPH) in Biostatistics, Epidemiology or related discipline, such as Outcomes Research from an accredited institution, with a minimum of eight (8) years of relevant, post-graduation experience.
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Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Clinical Research, Patient Safety, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
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Ph. D. in Biostatistics, Epidemiology or alternative appropriate discipline. Emergency Care Systems; Informatics; AI/Machine Learning; Global and Population Health; Pediatric Emergency Medicine; Emergency Medical Services; Point-of-care Diagnostics; Pandemic Preparedness and Response; Digital Health; Healthcare Technologies; Translational Medicine and Clinical Trials.
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biostatistics job in Palo Alto, CA
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