Senior NONMEM Programmer, R Programming

This is a fully remote position, open to applicants in India, +2 more countries.

📋 Description

• Develop R and SAS programming scripts to create NONMEM analysis input datasets for pharmacokinetic (PK) and/or pharmacodynamic (PD) analysis.

• Adjust variable definition files for NONMEM input datasets.

• Conduct quality control (QC) on NONMEM input datasets produced by other project management support staff and document QC activities, findings, and subsequent actions.

• Produce NONMEM e-submission packages, which include input datasets, control files, output parameter files, output table files, and supporting documentation.

• Ensure that e-submission packages comply with naming conventions, formatting, folder structure, and assembly server specifications.

• Mentor new or junior members of the Clinical Programming (CPP) community on the DataFlow process.

• Assist new or junior CPP community members in navigating 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 Standard Operating Procedures (SOPs), job aids, templates, and training materials.

• Enhance CPP processes for dataset creation, dataset quality control, and e-submission package preparation.

• Facilitate the setup of secure exchange mediums.

⛳️ Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field.

• Minimum of 6 years of SAS programming experience working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent experience.

• At least 4 years of relevant experience with a master’s degree or higher.

• Strong skills in SAS data manipulation, analysis, and reporting.

• Extensive experience in implementing CDISC SDTM / ADaM standards.

• Exceptional quality control and validation skills.

• Proficient in ad-hoc reporting.

• Expertise in efficacy analysis.

• Familiarity with the drug development lifecycle and clinical trial data manipulation, analysis, and reporting.

• Experience with submissions utilizing define.xml and other related submission documents.

• Excellent analytical and troubleshooting abilities.

• Capability to deliver quality outputs and deliverables within tight timelines.

• Ability to effectively collaborate in a globally distributed team environment with cross-cultural partners.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.

• Autonomy and ownership over work.

• Collaboration with global and cross-cultural teams.