Job Details
Clinical Programmer
5403
Posted: 05/03/2025
- £Competitive
- Home Based , Poland
- Permanent
Clinical Programmer - FSP| Global CRO | Home Based |
Poland | Romania | Bulgaria | Slovakia |Estonia | Hungary | Czech Republic | Serbia |
Join a leading CRO on an exciting BioPharma project! We have an incredible opportunity for several Clinical Programmers with strong expertise in SDTM and CDISC standards to join them. In this role, you will play a key part in transforming raw clinical data into high-quality, submission-ready datasets while ensuring compliance with regulatory and industry standards.
What you will be doing:
What you will need:-
This is a fantastic opportunity for a Clinical Programmer who thrives in a data-driven environment and is passionate about delivering high-quality, submission-ready datasets. If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the Clinical Programmers onboard as soon as possible.
Not what you’re looking for?
Please contact Jo Fornaciari on +44 7488 822 859 for a confidential discussion about potential opportunities.
Poland | Romania | Bulgaria | Slovakia |Estonia | Hungary | Czech Republic | Serbia |
Join a leading CRO on an exciting BioPharma project! We have an incredible opportunity for several Clinical Programmers with strong expertise in SDTM and CDISC standards to join them. In this role, you will play a key part in transforming raw clinical data into high-quality, submission-ready datasets while ensuring compliance with regulatory and industry standards.
What you will be doing:
- Develop, validate, and maintain SDTM datasets in compliance with CDISC guidelines and regulatory requirements.
- Use SAS to create, test, and optimize scripts for data transformation, validation, and reporting.
- Ensure accurate mapping of clinical data to SDTM specifications, including Define.xml and annotated CRFs.
- Collaborate with clinical and statistical teams to ensure data integrity and adherence to CDISC/CDASH principles.
- Implement quality control processes to validate data consistency across eCRF, external sources, and submission datasets.
- Create and maintain automated SAS macros to streamline SDTM programming and data processing.
- Work with CROs and internal teams to oversee data transfers and ensure compliance with submission requirements.
- Generate regulatory submission deliverables, including SDTM datasets, metadata, and reviewer guides.
What you will need:-
- Proficiency in SAS programming with hands-on experience in SDTM dataset creation and validation.
- In-depth knowledge of CDISC standards (SDTM, ADaM, CDASH, Define.xml) and regulatory submission requirements.
- Strong SDTM experience.
- Knowledge of the differences between legacy tabulation data and SDTM standardized tabulations.
- Strong experience in clinical data management, mapping, and transformation.
- Familiarity with eCRF design, external data sources (ePRO, IxRS, labs, ECG), and data reconciliation processes.
- Excellent problem-solving skills and attention to detail in ensuring data quality and compliance.
This is a fantastic opportunity for a Clinical Programmer who thrives in a data-driven environment and is passionate about delivering high-quality, submission-ready datasets. If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the Clinical Programmers onboard as soon as possible.
Not what you’re looking for?
Please contact Jo Fornaciari on +44 7488 822 859 for a confidential discussion about potential opportunities.
Jo Fornaciari
Principal Consultant in Statistical Programming
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