Implements, oversees, and supports standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis; Plans and implements statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing, and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study-related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model; Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents; Oversees statistical work performed by CROs in a full-service CRO model
Requirements:
Doctorate degree and 2 years of biostatistics experience
Text:
Biostatistics Senior Manager, Biosimilars Implements, oversees, and supports standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis; Plans and implements statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing, and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study-related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), and other communications in close partnership with CROs in a full-service CRO model; Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents; Oversees statistical work performed by CROs in a full-service CRO model Doctorate degree and 2 years of biostatistics experience
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