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) evaluation.

• Update variable definition files for NONMEM input datasets.

• Conduct quality control (QC) on NONMEM input datasets produced by other project management support personnel, documenting findings and necessary follow-up actions.

• Create and compile electronic submission packages for NONMEM analyses, encompassing datasets, control files, output files, and supporting documentation.

• Work in conjunction with the EPOD team to ensure electronic submission packages adhere to the appropriate structure and formats.

• Mentor new or junior members of the CPP community in the DataFlow and Data Collection Tools review processes.

• Collaborate with Data Management, Programming, BAN/BDS, EPOD, and external vendors regarding data collection, formatting, and representation.

• Revise, enhance, and produce standard operating procedures (SOPs), job aids, templates, and training materials.

• Streamline dataset creation, dataset QC, and electronic submission package preparation processes.

• Assist in setting up secure exchange mediums.

⛳️ Requirements

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

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

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

• Experience as a study lead is preferred.

• Proficient in SAS data manipulation, analysis, and reporting.

• Strong background in implementing CDISC SDTM / ADaM standards.

• Excellent QC/validation abilities.

• Competent in ad-hoc reporting.

• Expertise in efficacy analysis.

• Familiar with the drug development life cycle.

• Experience in manipulating, analyzing, and reporting clinical trial data.

• Familiarity with submissions using define.xml and other submission documents.

• Experience supporting studies in immunology, respiratory, or oncology is advantageous.

• Exceptional analytical and troubleshooting capabilities.

• Capacity to produce high-quality output and deliverables within tight deadlines.

• Ability to collaborate effectively within a globally dispersed, cross-cultural team environment.

🏝️ Benefits

• Ongoing training, development, and support.

• Substantial opportunities for professional growth.

• Independence and ownership over work.

• A collaborative, globally dispersed team atmosphere.

• Opportunities for cross-cultural collaboration.