Statistical Programming

FMD K&L’s statistical programming team provides excellent SAS programming services to the pharmaceutical and biopharmaceutical industries, including:

  • Development of study data tabulation model (SDTM) datasets
  • Development of analysis datasets (ADaM)
  • Development of standard exchange of non-clinical data (SEND) datasets
  • Creation of tables, listings, and figures (TLF), in-text tables & appendices
  • Support of clinical study report (CSR), integrated summary of safety & efficacy (ISS/ISE), interim analysis, agency filings, safety surveillance & publications
  • Support of database edit checks, query creation, patient profiles & ad-hoc reports, as well as data review and monitoring tools such as SpotFire
  • Support of data monitoring committee (DMC) meetings as unblinding programmers
  • Support for statistical method development, simulations, sample size calculations, exploratory analysis, and research projects

The life science industry’s demand for sophisticated analysis and high-quality reporting outputs makes SAS the ideal programming tool ensuring accuracy and efficiency. With more than 20 years of SAS programming experience, FMD K&L has been helping sponsors deliver complex solutions on time and within budget.

Experience and expertise matters

Our dedicated programming team has in-depth knowledge and expertise in your specific therapeutic area, allowing for fast and seamless completion of tasks, delivering high-quality output every time.