Biostatistics Manager

Job Description

REQUIREMENTS

Doctorate degree OR Master’s degree and 3 years of Statistics/Biostatistics experience OR Bachelor’s degree and 5 years of Statistics/Biostatistics experience.

RESPONSIBILITIES

• Providing statistical contributions, statistical review, and quality control of Key Design Elements (KDE) 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), clinical publications, and other communications
• Completing statistical analysis of individual studies/projects
• Publishing applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
• Being familiar with statistical policy and strategy at our client’s.
• Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
• Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within our client’s.
• Assisting in the review of our client’s Policies, SOPs, and other controlled documents
• Assisting with study and systems audits conducted by our client’s CQA and external bodies
• Serving as team member of change / process improvement initiatives

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