PK/PD Statistical Programmer – homebased

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

📋 Description

• Program, validate, and deliver datasets suitable for NONMEM based on SDTM/ADaM standards, utilizing advanced skills in R programming.

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

• Execute programming tasks of medium to high complexity independently, ensuring excellent accuracy and timely delivery.

• Conduct thorough reviews of data to identify inconsistencies or gaps, proposing solutions to enhance dataset quality and programming efficiency.

• Carry out quality control (QC) of NONMEM datasets, including those generated by external partners.

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

• Perform QC on customized R packages utilized in pharmacometrics workflows; improve or create automated test suites as necessary.

• Collaborate with cross-functional teams, including Data Management, Biostatistics, Statistical Programming, and Bioanalytical groups, to resolve data issues and ensure alignment.

• Follow relevant SOPs, working instructions, and regulatory standards while maintaining inspection readiness.

• Act as a technical leader in the development and enhancement of new PM standardization initiatives related to dataset creation and QC.

⛳️ Requirements

• Bachelor’s or Master’s degree in health, science, IT, mathematics, or a related field.

• A minimum of 6 years of industry experience in clinical data analysis, statistical programming, or pharmacometrics support.

• Expert-level proficiency in R for data processing, dataset creation, and QC automation.

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

• Strong understanding of SDTM, ADaM, and controlled terminology.

• Applied knowledge of PK/PD principles and clinical trial concepts.

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

• Capability to work both independently and collaboratively within global, cross-functional teams.

🏝️ Benefits

• Flexible work arrangements.

• Professional development opportunities.