Waltham, MA | Perm

Post Date: 07/10/2018 Job ID: 226778 Industry: IT



Responsibilities include: Develop statistical programs in SAS to generate the clinical datasets, tables, listings and figures. Perform validation and QC of the programs, datasets and statistical reports per study requirements. Develop and review Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) mapping specifications. Responsible for study closeout and providing submission-ready statistical programming deliverables to the client. Ensure compliance of CDISC SDTM and ADaM datasets by running Open CDISC validator and documenting issues. Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide. Ensure review of study documents such as Protocol, CRF, and SAP. Communicates effectively within a project team to complete assigned tasks on time and within budget. Effectively implement and promote use of established standards, SOP and best practices. Provide training and mentoring to junior programmers in the team.


Must have a Master’ s degree in pharmacy, medicine, biostatistics or a closely related field.
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