Address
Form of work Responsibilities:
Requirements:
- Review key study documents produced by other functions (protocols, statistical analysys plans [SAPs], TFL shells, case report forms)and interact with Statisticians and other clinical team members to ensure programming requirements are understood.
- Follow SAPs, develop specifications and execute derivation algorithms for analysis dataset production. Follow the SDTM and ADaM Implementation Guide to develop specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets and define.xml files.
- Generate tables, figures, and listings, (TFLs) in accordance with the SAP and TFL shells to support analyses using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology.
- Create and maintain integrated analysis datasets including closed and ongoing studies. Validate SAS programs, macros, datasets, and TFL output generated by other Programmers. Develop or assist in the development of departmental processes and procedures.
Requirements:
- Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical Programmer is required (>= 3 years with MS degree; >=5 years with BS degree).
- High proficiency in SAS programming and Macro development
- Experience working with CDISC SDTM and ADaM compliant data sets
- Experience with regulatory submissions and creating Define.XML.
- Knowledge of statistics and the drug development process
- Bachelor's /Master's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required;
