Minimum Requirementsbr Bachelors degree or foreign equivalent in Statistics, Mathematics, Pharmaceutical Studies, or a related field and 5 years of progressive experience in the biotech or pharmaceutical industry with a focus on statistical programming and analysis.br br Experience must includebr br 5 years of experience with each of the followingbr Utilizing SAS Base programming including SAS STAT, GRAPH, or MACRO.br Providing statistical programming support for clinical trials and working with clinical trial data.br 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 br 3 years of experience with each of the followingbr Utilizing clinical databases to work with clinical data.br Working knowledge of CDISC or submissions.br br 1 year of experience with each of the followingbr Working knowledge of the drug development process and clinical trials.br Working knowledge of the regulatory submissions process for submitting data to regulatory agencies, including drug submission requirements; relevant ICH; and FDA, EMA, or ROW guidelines.br Utilizing UNIX, Windows, or similar platform.
Categories: eb3
0 Comments