Clinical Pharmacology and The Role of PK Programmer

Statistical Programmers with PK/PD expertise possess different programming skills compared to other highly skilled programmers. There is a basis for why this programming has some different educational and experience requirements. Understanding pharmacokinetics / pharmacodynamics is a good basis.

Here’s what Programmers with PK/PD experience bring forth:

  • Experience with PK data structures such as PKS, NONMEM, POPPK, Exposure-Response
  • Work with clinical pharmacologists
  • Have knowledge of modeling and simulation programming
  • Program PK TLGs, particularly graphs
  • Understand PK terminology

SAS® is the appropriate statistical analysis system for the pharmaceutical industry to develop and perform quality control on analysis datasets and tables, figures and listings, and for programming statistical analyses (via analysis datasets, tables, figures, listings, etc.); however, Phoenix WinNonlin, is a powerful tool tailored to the specific demands of PK data, widely accepted as the industry standard for PK data analyses.

Relationships the PK Programmer will have been with Statisticians because they provide input to the statistical analysis plan, the table shells, data integration plans, and publications. This is not to say that these programmers wouldn’t work with other departments to properly implement data models (e.g. SDTM/ADaM). They collaborate with others to develop quality reports, publications and regulatory submissions.

Research is required of the PK Programmer to identify new technologies and techniques to improve efficiency of programming and assist in developing new processes. A blog that is part of a series on PK/PD that addresses some new research being done in this area is called ADNCA and the PK Submission.

Mentoring is a given expectation of the PK Programmer considering all he/she does. Along the way with helping to ensure the accuracy and consistency of data flow from case report forms (CRFs) and database definitions, through to and specifications for analysis, this expert performs quality review of analysis dataset and TLF programs developed by other programmers and biostatisticians; they verify that all statistical analysis system programs and associated documentation are archived following the creation of the final products and reviews and provides feedback regarding statistical analyses. Finally, you will find them maintaining libraries of documented and validated programs, macros, and procedures which can be reused to aid their department. Mentoring is seen through and through for this position.

The PK Programmer will want to have good working knowledge of the reporting and FDA submission process, be strong in ADaM and TLF’s, have a handful or more years of programming experience and it doesn’t hurt to call out those therapeutic areas of experience.

DataCeutics is Shaping the Future of Medicine by employing programmers who are forward thinkers, innovators that refuse to settle, those who push boundaries and use the latest technology and tools in the industry to push the momentum of an already growing company forward.

The video featured in the blog was selected based on a study conducted of the better educational videos on YouTube.