Statistical Programmer

Job description

Statistical Programmers (SP) within the ERGOMED Biostatistics (BS) department are responsible for programming tables, listings and figures or other types of output, supporting the Statisticians and Data Managers of a project and creating, updating and filing BS documentation. The Statistical Programmer within ERGOMED BS represents a position under direction of the Head of Biostatistics supervised by the Statistician.

Duties and responsibilities of the Statistical Programmer are:

• Assist Database Developer with the development of the Clinical Database
• Assist in preparation of treatment assignment randomization.
• Assist Database Developer/Data Manager with the import of external data into the clinical database.
• Import data from the clinical database and other data sources for purposes of statistical analysis.
• Export data from the clinical database and SAS analysis data sets, e.g. in CDISC SDTM and/or ADAM format.
• Program tables, listings and figures in SAS.
• Program derivations for the creation of SAS analysis data sets.
• Export data from the analysis data sets, e.g. in CDISC ADaM format
• Assist with Data Management Plan (DMP)/Statistical Analysis Plan (SAP) writing.
• File project-related BS documentation (e.g. Statistical Analysis Plan (SAP), Program Validation Documentation etc.) in the BS TMF
• Assist with Clinical Study Report (CSR) compilation.
• Attend meetings with project team and/or client when needed.
• Reference: eqDo9Cr208yuNyDCGWh1K_bPtrl6R8ptbFDFiX6PGCo.

Qualifications

Previous experience as a statistical programmer preferably within a pharmaceutical, clinical or health care setting.