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 QC activities, findings and follow-up actions
• Generate NONMEM e-submission packages, including input datasets, control files, output parameter files, output table files and supporting documents
• Ensure e-submission packages meet naming conventions, formatting, folder structure and assembly server requirements
• Guide new or junior CPP community members through the DataFlow process
• Guide new or junior CPP community members through the Data Collection Tools review process
• Collaborate 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 CPP processes for dataset creation, dataset QC and e-submission package preparation
• Support Secure exchange medium setup

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or 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
• 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 and clinical trial data manipulation, analysis and reporting
• Submissions experience utilizing define.xml and other submission documents
• Excellent analytical and troubleshooting skills
• Ability to provide quality output and deliverables within challenging timelines
• Ability to work effectively in a globally dispersed team environment with cross-cultural partners

• Consistent training, development and support
• Significant professional growth opportunities
• Autonomy and ownership
• Collaboration with global and cross-cultural teams