Senior NONMEM Programmer, R Programming

• Prepare R and SAS programming scripts to generate NONMEM analysis input datasets for PK and/or PD analysis
• Modify variable definition files for NONMEM input datasets
• QC NONMEM input datasets generated by other PM support staff and document findings and follow-up actions
• Generate and assemble e-submission packages for NONMEM analyses, including datasets, control files, output files and supporting documents
• Collaborate with the EPOD team to ensure e-submission packages have the correct structure and formats
• Guide new or junior CPP community members through DataFlow and Data Collection Tools review processes
• Interact with Data Management, Programming, BAN/BDS, EPOD and external vendors on data collection, formatting and representation
• Revise, update and create SOPs, job aids, templates and training materials
• Improve dataset creation, dataset QC and e-submission package preparation processes
• Support Secure exchange medium setup

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field
• At least 6 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent
• At least 4 years of related experience with a master’s degree or above
• Study lead experience preferred
• Strong SAS data manipulation, analysis and reporting skills
• Solid experience implementing CDISC SDTM / ADaM standards
• Strong QC / validation skills
• Good ad-hoc reporting skills
• Proficiency in efficacy analysis
• Familiarity with the drug development life cycle
• Experience manipulating, analyzing and reporting clinical trial data
• Submissions experience using define.xml and other submission documents
• Experience supporting immunology, respiratory or oncology studies is a plus
• Excellent analytical and troubleshooting skills
• Ability to provide quality output and deliverables within challenging timelines
• Ability to work effectively in a globally dispersed, cross-cultural team environment

• Consistent training, development and support
• Significant professional growth opportunities
• Autonomy and ownership
• Collaborative, globally dispersed team environment
• Cross-cultural collaboration