Senior/Principal Statistical Programmer FSP (Remote)

Tasks

• Create clinical graphs
• Create clinical listings
• Create clinical tables
• Define ADaM datasets
• Define definexml files
• Develop CRFs
• Develop SAS programs
• Develop data validation plans
• Develop edit check specifications
• Develop standards for programming tools outputs and macros
• Develop validate and maintain R programs
• Develop validate and maintain SAS programs
• Ensure deliverables meet timelines
• Follow FDA regulations
• Generate ADaM specifications
• Generate SDTM specifications
• Implement good clinical practice
• Oversee CRO statistical programming deliverables
• Prepare clinical study reports
• Prepare regulatory submissions
• Review and author SOPs
• Review and author data transfer specifications
• Review and author work instructions
• Support DSUR preparation
• Support exploratory analyses

Perks/Benefits

• Development
• Remote work
• Support
• Training

Skills/Tech-stack

ADaM | Biostatistics | CDISC | CRF development | Clinical Practice | Clinical Trial Methodology | Clinical trial | Data Validation | Data transfer | Data transfer specifications | Data validation plans | DefineXML | Edit Check | Edit Check Specifications | FDA Regulations | Git | Good Clinical Practice | ICH | Instruction development | R | SAS | SDTM | SOP Development | Statistical programming | Trial methodology | Unix/Linux | Validation plans | Work Instruction Development | Work instruction