BIOGEN, INC. – $82,555.00/Year

Minimum Requirementsbr Bachelors degree or foreign equivalent in Statistics, Mathematics, Biology, Chemistry, Pharmaceutical Sciences, or a related field and 3 years of experience in the biotech, pharmaceutical, or health sciences industry or in a related consulting firm, with a focus on data analysis.br br Experience must includebr br 3 years of experience with each of the followingbr Creating, modifying, and analyzing data or summary reports related to biotech, pharmaceutical, or health sciences with a knowledge of programming tools.br Validating summary reports for clinical trials or health sciences data in compliance with 21 CFR Part 11.br Creating requirement specifications as per standard operating procedures.br Knowledge of the drug development process.br Utilizing UNIX environment.br br 1 year of experience with each of the followingbr Knowledge of industry and regulatory data standards Clinical Data Interchange Standards Consortium CDISC including Standard Data Tabulation Model SDTM and Analysis Data Model ADaM.br Knowledge of regulatory submission requirements for submitting data to regulatory agencies including ICH guidelines.