With guidance, you will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc
Requirements:
PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment. PhD with 2+ years’ biostatistics experience is preferred; MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software; Multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams; Significant biomedical statistical analysis experience and experience working with relevant software
Text:
Sr. Manager, Biostatistics - Clinical Drug Dev - Virology With guidance, you will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment. PhD with 2+ years’ biostatistics experience is preferred; MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software; Multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams; Significant biomedical statistical analysis experience and experience working with relevant software
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