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The Senior Director in Biostatistics is a core member of the Evidence Generation Team (EGT), support design, analysis, interpretation and reporting of clinical studies, regulatory submissions, Health Technology Assessments (HTA) and payer submissions, and dissemination of clinical data insights.
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BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences - 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
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Qualifications Must have an MD or MD/PhD with: 3+ (for a board eligible or certified oncologist), 5+ (if no formal oncology training) years of experience at a pharmaceutical or biotechnology company as a (Associate) Medical Director.
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Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes.
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PhD in Biostatistics or related field with 5+ years of experience in pharmaceutical or biotechnology drug development. You will have the opportunity to lead biostatistics activities for innovative clinical trials, contributing to the development of cutting-edge treatments for various diseases.
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To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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.
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Some of these services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice is a leading full-service clinical CRO dedicated to offering high-quality one-stop service to pharmaceutical, biotechnology, medical device, and consumer products clients.
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Must have an MD or MD/PhD with: 3+ (for a board eligible or certified oncologist), 5+ (if no formal oncology training) years of experience at a pharmaceutical or biotechnology company as a (Associate) Medical Director.
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Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies. and study-level teams both internally and within the joint execution team (JET) with our partner Gilead, with minimal oversight by our senior clinicians, to oversee the design and conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
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Experience with interpretation of clinical research results including safety and efficacy required. Familiarity with pharmacovigilance and statistical principles desirable. Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy.
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Ability to think strategically, innovatively, and tactically with an interest in clinical research and drug development. Provide organizational support for Data Monitoring Committees and other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
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The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. This role will work on cross-functional program development and study management teams for the design, execution, and (medical) monitoring of clinical trials, in close collaboration with our clinical science group, as well as assist with data interpretation and communication to both internal and external stakeholders.
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Prepare and communicate a clear overview of trial results for internal presentations, external scientific publications and regulatory purposes. Must have experience in oncology or malignant hematology.
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Author protocols and contributes to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents. This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based.
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Present at investigator meetings and scientific conferences. May be responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
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