PK/PD Statistical Programmer (m/w/d) - homebased

Description

The company is looking for a PK/PD statistical programmer with solid experience in R, PK/PD datasets and NONMEM dataset creation. The role supports pharmacometrics work by building accurate, compliant datasets for modelling and analysis, from unclean early data through to locked clinical data. You bring strong technical depth, good problem-solving ability and a working grasp of PK/PD principles.

Responsibilities

• You will build, check and hand over NONMEM-ready PK/PD datasets that follow SDTM and ADaM standards, using advanced R.
• Produce these datasets from both pre-lock and post-lock clinical data.
• Work independently on programming tasks of medium to high complexity, keeping accuracy high and meeting deadlines.
• Review data critically, spot inconsistencies or gaps, and suggest fixes that improve dataset quality and coding efficiency.
• Run quality control on NONMEM datasets, including those delivered by external partners.
• Help prepare regulatory submission deliverables in line with internal pharmacometrics guidelines.
• Review customised R packages used in pharmacometrics workflows, and build or extend automated test suites where needed.
• Work with Data Management, Biostatistics, Statistical Programming and Bioanalytical colleagues to resolve data issues and keep everyone aligned.
• Follow relevant SOPs, working instructions and regulatory standards, and keep the team ready for inspection.
• Act as a technical lead in new pharmacometrics standardisation work on dataset creation and QC.

Requirements

• A bachelor's or master's degree in health, science, IT, mathematics or a related field.
• At least 6 years of industry experience in clinical data analysis, statistical programming or pharmacometrics support.
• Expert-level R skills for data processing, dataset creation and QC automation.
• Hands-on experience building NONMEM datasets, including complex structures for PK/PD analyses.
• A firm grasp of SDTM, ADaM and controlled terminology.
• Working knowledge of PK/PD principles and clinical trial concepts.
• Careful attention to detail, with good analytical, documentation and communication skills.
• Comfortable working alone and as part of global, cross-functional teams.
• Preferred, not required: experience building or improving standard workflows for NONMEM dataset creation, submission packages and QC.
• Preferred, not required: experience with R package testing, validation frameworks or reproducible programming.
• Preferred, not required: familiarity with pharmacometrics workflows in clinical or real-world settings.

Conditions

Homebased role.

Equal opportunity applies; all applicants are considered on merit.