Job Description Supports the Biostatistics Team by providing analysis and interpretation of study datasets, providing statistical consultation during all phases of a study. Develops program code for manipulation and analysis of study datasets, including graphics and tables for the presentation / reporting of clinical data using SAS and/or other statistical packages.
1. Develops statistical methods and programs, analyzes data, and writes statistical reports to achieve objectives within given timelines. 2. Advises on the design of titration, pilot, and pivotal efficacy studies, pilot and pivotal target animal safety studies. 3. Designs, implements, and tests programs for statistical analysis of assigned studies. Develops tables and graphs for inclusion into statistical reports, safety reports, Final Study Reports, presentation slides, and publications. 4. Supports the development and maintenance of the library of SAS (Base, STAT, Graph, ODS) and other statistical programs. Develops and maintains a repository of statistical literature. 5. Understands and proactively utilizes knowledge of pertinent local and/or international Regula-tory Requirements, and may participate in or lead interactions with local Regulatory Agencies under the guidance of more experienced Biostatisticians. 6. Attends working groups, conferences, and technical meetings. 7. Collaborates with other associates to facilitate knowledge exchange. 8. Assists in the preparation SOPs related to job function. 9. Works following external and internal guidelines (e.g. SOP’s, GxP, HSE, AW).
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Statistical thinking will one day be as necessary for efficient citizenship as the ability to read and write." H.G.Wells
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