SAS Consultant

Description

REQUIREMENTS & QUALIFICATIONS FOCUS on candidates with Strong SAS macro skills, CDSIC standard knowledge and Submission experience. Bachelors degree in life science, statistics, mathematics, computer science, or related field is required; Masters degree is preferred. 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelors degree; or 5 plus years of experience with a MS/MA degree. Experience in Oncology, Hematology Cancer (i.e. CLL) and Medical Affair Projects are preferred. Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs. Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats. Demonstrated skills in using additional software tools and applications (e.g. MS office, XML). Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, esubmission. Indepth understanding of regulatory, industry, and technology standards and requirements. Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Good interpersonal, communication, writing and organizational skills.