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Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies. This opportunity will be reporting to the Vice President, Biostatistics.
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Experience with the relevant regulatory requirements for biostatistics processes and SOPs. CTT member:Participate and represent Biostatistics. At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
$170,625 - $284,375 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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Master’s degree from an accredited university in fields such as outcomes research, epidemiology, biostatistics, data science, predictive analytics with 3 years relevant work experience is required; a doctoral degree (PhD, DrPH, ScD) is preferred.
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Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.
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Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development.
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Fresh PhD or MS with 2+ years' experience in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience. The Senior Manager of Biostatistics is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization.
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PhD in statistics or biostatistics preferred. Work closely with internal statistical programmer. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies.
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These individuals develop collaborative relationships and work effectively with the Biostatistics Lead, and other cross functional team members. In oncology, hematology, cell therapy, immunology, neuroscience, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change.
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A Ph. D. in physical geography, statistics/biostatistics, environmental, climate, atmospheric, physical sciences is required. The health impacts of rising temperatures in a changing climate are expected to be many, including greater incidence of heat-related illnesses, water- and vector-borne diseases, reduced food security, and mental health impacts (National Climate Assessment, 8.
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Experience with drug development process, including affinity with clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management.
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Liaise with the Heads of Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacology, Biostatistics and Data Management as needed for the clinical studies. Liaise with the Heads of Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacology, Biostatistics and Data Management as needed for the clinical studies.
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Educational background in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
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A Master’s degree or PhD in the field of psychology, psychometrics, sociology, health economics, biostatistics, epidemiology, public health or health services research, or PharmD. A Master’s degree or PhD in the field of psychology, psychometrics, sociology, health economics, biostatistics, epidemiology, public health or health services research, or PharmD.
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biostatistics job in Lawrence, NJ
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