Biostatistics and Programming

LLX biostatisticians and statistical programmers provide comprehensive biostatistics and statistical programming services to support clinical, pre-clinical and patient reported outcomes for pharmaceutical, medical devices and biotech companies.

Biostatistics services include:

  • Trial design and protocol development
  • Sample size calculation/justification
  • Randomization schemes
  • Statistical analysis plan (SAP) for different phases of clinical studies
  • SAP for Integrated safety and effectiveness (ISS/ISE)
  • SAP for briefing documents to regulatory agencies and publications
  • Data Monitoring Committee/independent statistician  services

Statistical programming services include: 

  • Data conversion
  • CDISC-compliant and submission-ready datasets and  documents
  • Statistical tables, listings, and figures for clinical study reports
  • Pharmacokinetic and pharmacodynamic analyses dataset preparation