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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and GCP. Assess and oversee the activities for monitoring adverse event reports for potential drug-safety related issues and provides recommendations when potential issues are identified.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Through our Lifecycle Evidence Strategy, Clinical Trial Optimization, Medical Affairs and Real World Evidence services, we deliver impact where it matters, from early drug development to commercialization.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Solid understanding of drug development, clinical research, study design, pharmacokinetics, and medical terminology. Ph. D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 2 years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 4 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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Serve as the biostatistician in the Clinical Operations and Development team, responsible for all clinical study biostatistics deliverables. Dragonfly Therapeutics seeks an Associate Director, Biostatistics to lead, develop, and implement statistical analyses to support our early development clinical trials, and provide support to investigators and researchers on experimental design and statistical approaches, requirements, and scientific standards.
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Provide scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff. Reporting to the CMO, the Medical Director/Senior Medical Director, Clinical Development will play a key role at all stages of clinical development programs from the drug discovery stage through product registrations world-wide.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process. Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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When required, serve as a principal level Statistical Programmer, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Reporting to the Head of Biometrics, the Director of Biostatistics will support oncology drug development, providing statistical leadership and oversight to the development plans, regulatory interactions, and commercial evaluation of investigational compounds in one or more indications.
$190,000 - $250,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP). Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
RemoteExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Represent and provide clinical pharmacology expertise and leadership at cross-functional development project team, clinical subteam, study team, partnering with clinical research, biometrics, project management, clinical operations, drug metabolism, biology/biomarkers, toxicology etc.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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5+ years of related experience, including 3 years of relevant industry experience, preferably in data services (data management and biometrics) or a clinical research environment. We are currently looking to strengthen our Business Development team through the recruitment of a Director, Business Development to support our business development activities.
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The Biometrics Department is seeking a Senior Manager of Biostatistics, reporting to the Head of Biostatistics, who will implement statistical strategy to optimally support drug development across Cerevel clinical programs.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Ability to lead and manage a matrixed Program team and coordinate cross-functional aspects of drug development (e.g., medical, regulatory, clin ops, safety, biometrics, quality, supply, etc.
ExpandApply NowActive JobUpdated 3 days ago
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