Clinical Programmer

A world leading CRO is looking to hire a Clinical Programmer to join them on a permanent basis. This is a fully remote role, and candidates can be based in a number of countries including Lithuania, Serbia, Poland, Bulgaria, Romania, Estonia etc.

Applicants must have solid experience in writing SDTM specifications.

The Clinical Programmer will focus on the development of programming scripts for data retrieval, transformation and representation as well as validation. You will lead the development and maintenance of data quality standards and perform the necessary programming and validation steps to ensure that regular and on-demand data quality control can be performed in clinical studies.

The role will support the clinical study team with the identification, specification, and implementation of relevant listings and reports to ensure that adequate data quality will be achieved for clinical trials. Furthermore, the role will lead the development and implementation of programs to ensure the quality of data deliveries as they are provided by contract research organizations. These are mainly but not limited to eCRF raw data, datasets in submission ready standard format (SDTM, ADaM), and data from external sources as they have been collected in clinical trials (eg, IxRS systems, eDiary, central laboratory, central ECG) and their related documentation.

Key Responsibilities:

• Utilize existing SAS macros for data centralization.
• Update SAS macros based on new requirements or specific file transfer needs.
• Use SAS code to interpret study documentation and classify legacy data.
• Automate processes that are currently done manually, such as filling in trackers.
• Perform statistical analyses and SAS programming to:

support clinical safety monitoring of safety signals

generate integrated summary of safety and efficacy

support publications and presentations

support planning and reporting of clinical trials via exploratory analyses of available data

Experience:

• At least 4+ years of experience in either clinical data management and/or statistical programming/SAS Programming, within CRO/pharmaceutical environment.
• Understanding of data management and/or statistical programming processes and standards.
• Experience in statistical programming using SAS software or reports programming.
• Strong SAS Macro Programming skills
• Knowledge in CDISC standards (CDASH, SDTM, ADaM)
• Strong understanding of different study deliverables and their information types.
• Knowledge of the differences between legacy tabulation data and SDTM standardized tabulations.

For additional information and a confidential discussion, please apply now with an updated CV.