Statistical Programmer

at

Ergomed

Cologne, Germany
Full Time
3y ago

Company Description

Founded in 1997 by a Medical Doctor , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

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.

Qualifications

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

Additional Information

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to develop a career in clinical drug development. 

 

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