VERTEX PHARMACEUTICALS INCORPORATED – $101,026.00/Year

Position requires a Master of Science degree or foreign equivalent in Biostatistics, Computer Science, or Statistics, or a related field plus five 5 years of experience in the job offered or in a Principal Statistical Programmerrelated position in the Pharmaceuticals or Clinical Research Organization industries. Experience must include the followingbr Demonstrable experience of coding and programming in SAS including the macro language, SASGRAPH, and SASSQL;br Demonstrable experience with CDISC SDTM and ADaM models and transforming raw data into these standards;br Demonstrable experience working with all types of safety data and coding dictionaries MedDRA and WHODD;br Demonstrable knowledge regarding software validation and system development life cycle conceptsbr Basic knowledge on statistical concepts used in analyzing clinical trial data; linear regression, mixedmodel for repeated measures, survival analysis, analysis of variance, hypothesis testing, chisquare goodness of fit test etc;br Experience in creating complete submission packages to regulatory agencies FDA, EMA, etc.; define.xml, reviewer guides, executable codes, BIMO package, TFLs for CSR appendices, Day 90, or 120 reports etc.; and,br Demonstrable experience with Data Analytics.br 100 telecommuting permitted.