Statistical Programmer II

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Create and ensure the quality of NONMEM PK/PD datasets utilizing SDTM and ADaM data sources.

• Assist in pharmacometric modeling efforts by providing datasets that are accurate, comprehensive, and ready for submission.

• Conduct quality reviews of NONMEM datasets produced both internally and externally.

• Work collaboratively with teams in Data Management, Statistical Programming, Statistics, Clinical Pharmacology, and Bioanalytical areas to address data issues and adhere to project deadlines.

• Participate in regulatory submission initiatives while following internal pharmacometrics guidelines.

• Execute quality control testing on customized R packages designed to standardize pharmacometric workflows.

• Develop and sustain testing frameworks and validation processes for departmental R tools and packages.

• Recognize data discrepancies, identify process enhancements, and explore opportunities for automation and increased efficiency.

• Contribute to new initiatives aimed at pharmacometric standardization.

• Ensure that deliverables align with SOPs, operational instructions, regulatory standards, and ICH-GCP guidelines.

• Maintain readiness for inspections through continuous training and adherence to quality benchmarks.

⛳️ Requirements

• A Bachelor’s degree in a Life Science, Health Science, Statistics, Computer Science, IT, or a related field.

• At least 6 years of experience in the pharmaceutical, biotechnology, or CRO sectors.

• Proficient programming skills in R.

• Experience in developing and ensuring the quality of NONMEM PK/PD datasets.

• Familiarity with PK/PD principles and pharmacometric workflows.

• In-depth knowledge of SDTM, ADaM, and CDISC standards, including controlled terminology.

• Background in supporting the creation, quality control, submission, and standardization of NONMEM files.

• Strong attention to detail and a commitment to maintaining data integrity.

• Exceptional written and verbal communication skills in English.

• Experience in reviewing and managing programming deliverables from external sources.

• Experience in validating or ensuring quality control for customized R packages.

• Proven ability to identify process improvements and lead standardization efforts.

• Capacity to work effectively within global, cross-functional teams.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• A collaborative working environment.

• Job stability and opportunities for career advancement.

• Chance to work within a globally recognized Clinical Pharmacology & Pharmacometrics function.

• Contribution to groundbreaking drug development projects.

• Engagement in ongoing innovation and standardization initiatives within pharmacometrics and clinical data science.