Senior Statistical Programmer
Tech Observer
Location Not Specified
Posted
Senior Level
Job Description
- Tech Observer is hiring Senior Statistical Programmers (FSP)Job responsibilities (but not limited to)Carry out all activities according to Tech Observer SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines.
- Understanding of Protocol and SAP requirements
- Lead the assigned project or task
- Write SAS/R programs for development and QC of SDTM datasets, ADaM datasets and reports (i.e. Tables, Listings and Figures)
- Write SAS programs for development and QC of Randomization Schedule
- Development and QC of SDTM and ADaM specifications
- Development and QC of e-submission package for SDTM and ADaM
- Review of study documents such as CRF, Metadata, Protocol, SAP and Mockshells
- Demonstrate excellent problem-solving skills, a proactive approach and a willingness to take decisions on a regular basis.
- Perform function/project specific responsibilities as assigned
- Demonstrate quick learning capabilities to improve programming and domain knowledge
- Provide support in the driving system and process improvements, and to develop and implement solutions to improve efficiency and quality of clinical study data processing and reporting
- Demonstrate 100% compliance and adherence to all SOPs
- Prepare and implement standard operating procedures (SOP)
- Write complex SAS macros
- Mentor junior statistical programmers and conduct knowledge sharing sessions
- Attend project/stake holder meetings and provide input as needed