Clinical SAS Programmer
Responsibilities:
- Provide statistical programming support per requests from Biostatisticians and other functional areas such as medical/clinical or medical writing
- Develop, maintain, and validate SAS program/macros for study specific analysis or at the standard level
- Generate TFLs per table shells or ad hoc requests; perform validation to TFLs that generated by other programmers per table shells or ad hoc requests
- Attend internal or cross-functional meetings with inputs from Statistical Programming group
- Oversee and manage programming activities which may be conducted by external vendors
- Work with external vendors in order to develop or monitor the content and structure of SAS and related Software installations
- Develop and maintain SOPs, Lifecycle Data Standards and other related technical documents, provide input and feedback
- Provide input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents and determining and researching SAS software upgrades and related system maintenance issues
- Write and Executing systems and macro testing, and deliver training
- Generate SDTM/ADaM datasets and associated specs files; perform validation to SDTM/ADaM datasets that generated by other programmers per specs files
Requirements:
- Experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment
- Experience in a pharmaceutical/CRO programming environment or demonstrated understanding of SAS programming activities in a clinical pharmaceutical/CRO environment
- Validation and Systems Development Life Cycle
- Experience using SAS-Base, MACRO, STAT, GRAPH, MS Office and R.
- Understanding of regulatory guidelines
- Hands-on experience with industry tools including biostatistics platforms, ETL, standard reporting and visualization tools