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PRIMARY OBJECTIVEOF THE POSITION:
The primary objective of the Biostatistician is to provide statistical expertise in the design and analysis of clinical studies, as well as the interpretation and reporting of the results.
EDUCATION AND EXPERIENCE:
The candidate should have a masters or doctoral level degree in statistics with at least 5-7 years of experience performing statistical analysis and reporting for clinical trials.
A thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines is essential. Excellent problem solving, organizational, written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical. Computer proficiency and SAS programming skills are required. Understanding of SDTM and ADaM standards. Ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.
MAJOR RESPONSIBILITIES AND DUTIES:
Biostatistician responsibilities include, but are not limited to:
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