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The EBM biostatistician provides statistical expertise for all observational research project sponsored by the Sanofi US Evidence Based Medicine (EBM) in protocol development, Statistical Analysis Plan (SAP) preparation and study report. The role needs to ensure that appropriateness of study design, sample size and statistical methodologies are used and adherence to the established standards and SOPs. The role manages the timely execution of statistical and research methodological components of EBM study protocols in order to meet project objectives and has a thorough understanding of current requirements for statistical standards.
Utilize statistical knowledge of and expertise to provide statistical support for EBM studies, with a main focus of real-world observational studies, database examples:
US medical and pharmacy claims databases (e.g. MarketScan)
US medical record databases (e.g. Client Healthcare); 3) US government public use databases (e.g. NHANES, MEPS)
Participate in study concept, protocol and SAP development and ensure appropriateness of study design, sample size and statistical methodologies proposed.
Specify the structure of the datasets that will be delivered for statistical analysis to ensure that the structure follows any existing company standard for databases pooling.
Mock-up, review, and approve tables, listings and graphs specifications.
Actively participate in project/study team meetings Establish/negotiate timelines for completion of study-related statistical activities. Ensure the study timelines are met.
Conduct observational data analysis, include data management, statistical programming, interpretation of analyses results, and write-up/review the corresponding sections of EBM study report.
Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and complying with pre-defined project / study standards.
Provide oversight of the biostatistics-related activities for EBM studies subcontracted to a CRO:
Oversee the CROs work on the preparation of analysis plans, development and validation of computer algorithms for inferential analyses, statistical writing of study reports, and other outsourced analyses as appropriate.
Perform quality control procedures to ensure that statistical deliverables conform to the requirements outlined in the SAP
Working knowledge and experience with bio statistical analysis and SAS programming.
Excellent oral and written communication skills in English are a must.
Prior work experience in epidemiology, health economic and outcome research, or clinical research area is a plus.
Specific experience and understanding of outcomes research, drug development is an asset Familiarity with observational databases desirable; database examples
US medical and pharmacy claims databases (e.g. MarketScan) US medical record databases (e.g. Client Healthcare) US government public use databases (e.g. NHANES, MEPS)
MS or Ph.D. in Statistics or related field
Minimum 5-year experience in pharmaceutical research or equivalent
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