Job Title

Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.Works to ensure that outputs meet quality standards and project requirements.Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.Keeps project team members informed of programming progress and issues requiring their attention and maintaining templates needed for the successful implementation of the project.Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload..Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.Interact with sponsors and internal stakeholders with regard to statistical programming issues.Assist project teams in the resolution of problems encountered in the conduct of their daily work.Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.Monitor project resourcing, project budgets, and identify changes in scopeFollows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).Develop and maintain global R codebase for generating CDISC ADaM datasets and tables, listings, and figures in accordance with clinical trial data requirementsContribute to process improvements and development of programming standards using RWork for R to SAS migration activities