- Manages several projects and work in more than one therapeutic area. - Provide adequate and qualified statistical and methodological support to Clinical Science. - Responsible for appropriate statistical methodology and endpoint definitions as part of the design of clinical studies and for the associated sample size determination. - Responsible for briefing the CRO to an appropriate conduct of statistical analysis of Clinical Operations studies. This entails review of the statistical analysis plan, participation in Blind Data Reviews, review of study report tables, listings and figures. - Supports dossier submissions and responding to queries from health authorities. This task includes the outline of an analysis, programming and writing the responses. - For purpose of integrated analyses of internal compound data bases that are accumulating, incumbent to write strategic and detailed integration plans in co- operation with Clinical for smooth execution. - Good at number crunching and understanding complex data trends through data integration and data utilization activities (meta-analyses, data explorations). - Manage external study statisticians working on the analysis of clinical trial data. Briefs CRO's on methodological and statistical deliverables. - Reviews statistical literature and attends conferences and courses in order to ensure a high statistical expertise and maintain proficiency.

Bangalore

Biostatistician - Pharma 

Job Description for Biostatistician - Pharma  in Biojobz - Client company in  Bangalore for (8-20) years of experience. Apply Now!