PK/PD Statistical Programmer – homebased

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Develop, validate, and produce NONMEM-compatible PK/PD datasets adhering to SDTM/ADaM standards utilizing advanced R programming expertise.

• Generate high-quality PK/PD datasets for both pre-lock and post-lock clinical data submissions.

• Execute programming assignments of moderate to high complexity independently, ensuring exceptional accuracy and adherence to timelines.

• Thoroughly review data to identify discrepancies or deficiencies, proposing solutions to enhance dataset quality and programming efficiency.

• Conduct quality control of NONMEM datasets, including those generated by external collaborators.

• Assist in the preparation of deliverables for regulatory submissions in accordance with internal Pharmacometrics protocols.

• Perform quality control on customized R packages utilized in pharmacometrics workflows and improve or create automated testing suites as necessary.

• Collaborate with Data Management, Biostatistics, Statistical Programming, and Bioanalytical teams to address data challenges and ensure consistency.

• Follow applicable SOPs, working instructions, and regulatory requirements while maintaining readiness for inspections.

• Act as a technical leader in new PM standardization projects related to dataset development and quality control.

⛳️ Requirements

• Bachelor's or Master's degree in a health, science, IT, mathematics, or a related discipline.

• At least 6 years of professional experience in clinical data analysis, statistical programming, or pharmacometrics support.

• Expert-level skills in R for data processing, dataset generation, and automation of quality control.

• Practical experience in creating NONMEM datasets, including intricate data structures for PK/PD analysis.

• Strong knowledge of SDTM, ADaM, and controlled vocabulary.

• Applied understanding of PK/PD concepts and clinical trial methodologies.

• Exceptional attention to detail, along with strong analytical, documentation, and communication capabilities.

• Ability to work autonomously and collaboratively within diverse, global teams.

• Experience in developing or enhancing standardized processes for NONMEM dataset creation, submission packages, and quality control.

• Familiarity with R package testing, validation frameworks, or practices that promote reproducible programming.

• Knowledge of pharmacometrics workflows in clinical or real-world scenarios.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to support work-life balance.

• Engaging and inclusive company culture.