Biostatistics and Statistical Programming

The Triangle Biostatistics team provides quality-driven operational and strategic statistics and statistical programming for clinical research and development. Our operational expertise allows us to deliver the high-quality statistical output required for every aspect of drug development including the statistical material you need for study reports and for regulatory responses.

Triangle Biostatistics was originally founded to provide statistics and statistical programming services to the pharmaceutical industry, it is at the core of everything we do. The experience of our founders and team is unparalleled in the industry.  Triangle Biostatistics has provided services for hundreds of studies across all major therapeutic areas.

BIOSTATISTICS SERVICES

  • Aspects of clinical trial design
  • Development of statistical analysis plans (SAP) and analysis
  • Sample size/statistical power determination
  • Randomization schedule generation
  • Development of tables, listings, and figures
  • Data and Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) support
  • Interim and final reporting
  • NDA: Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)
  • FDA and other regulatory interactions, including Advisory Committee meetings
  • Publication support and ad hoc Analyses
  • Statistical Consulting

SAS PROGRAMMING SERVICES

  • Experience with multiple EDC platforms
  • CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)
  • Derived dataset production and validation
  • TLF production and validation
  • Development of integrated ADaM datasets for ISS/ISE analyses
  • Submission-ready datasets and programs
  • Study rescue and legacy data requests