Statistical Programmer II

Responsibilities: Perform validation and QC of the programs, datasets and statistical reports per study requirements. Develop and review CDISC SDTM and ADaM mapping specifications. Responsible for study closeout and providing submission-ready statistical programming deliverables to the client. Develop statistical programs in SAS to generate the clinical datasets, tables, listings and figures. Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC 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. Provide training and mentoring to junior programmers in the team. 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. Requirements:

Master's degree or equivalent and relevant formal academic / vocational qualification. 5yrs SAS programming experience. 1-2yrs CDISC implementation experience. Proficient in SAS and Macros and have developed macros to automate functionality. Participated as production or QC programmer at a product and/or study level. Good organizational, interpersonal, leadership and communication skills. bility to independently manage multiple tasks and projects. Experience working in Oncology, CNS or Rare Disease therapeutic areas.