R Statistical Programmer - Submission Experience Required (hiring in Armenia, UK, India, SA)

Tasks

• Create dataset and output specifications
• Develop R code for summary tables data listings graphs derived datasets
• Develop programming tools and macros
• Follow SOPs and regulatory guidelines
• Lead statistical programming activities
• Maintain project documentation testing verification and quality control
• Manage scheduling for multiple projects
• Mentor programming personnel
• Participate in sponsor kickoff and bid defense meetings
• Perform CDISC compliance reviews for SDTM and ADaM including Define XML
• Perform validation programming
• Resolve programming discrepancies with biostatisticians
• Review Statistical Analysis Plan mock shells programming specifications annotated CRFs
• Serve as CDISC technical subject matter expert
• Transfer deliverables

Perks/Benefits

• Career development
• Inclusive culture
• Supportive line management
• Technical training
• Therapeutic training

Skills/Tech-stack

ADaM | CDISC | Clinical trials | Data Validation | Define-XML | Electronic submissions | ICH | Programming macros | R | S&OP | SAS | SDTM