Senior Biostatistician - StatWorks (Research Triangle Park, NC)

StatWorks, Inc. is a high quality specialty provider of biostatistical analysis and consulting, clinical data management, and report writing services focused exclusively on clinical trials and drug development. We are looking to grow our team of talented and experienced professionals by seeking a Senior Biostatistician.

The Senior Biostatistician will provide biostatistical and other technical support to the design and analysis of clinical studies.

Responsibilities:

• Assists the project team with designing clinical studies to evaluate the safety and effectiveness of health care products. Activities include protocol development, definitions of endpoints, sample size estimation, plans for data analysis, and case report form design.
• Assists with study implementation, which may include randomization scheme generation; and data base design through CRF design, variable name assignments and edit specifications.
• Develops detailed analysis plans, oversees or conducts these analyses, and provides statistical interpretation of results.
• Determines reporting requirements for clinical studies and, with the Programmer, designs appropriate reporting systems in SAS or other appropriate software. Writes programs, primarily in SAS, to produce these clinical reports. Reports include tables and graphs summarizing descriptive and inferential statistical analysis of clinical study results, or data management reports.
• Drafts text for inclusion in documents including protocols and study reports.
• Communicates with client and other project team members’ regarding project-related, technical matters.
• Assist with data base management, as required.
• Manage preparation of entire products – such as clinical protocols, clinical/statistical reports, or regulatory submissions – consistent with individual capabilities.
• Review documents for appropriateness of employed statistical methods.

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