Biomarker Statistics

As the era of the blockbuster drug fades, the pharmaceutical industry is leaning on the utility of biomarkers to help deliver on the promise of personalized medicine (also called tailored therapeutics, precision medicine or predictive medicine). To realize this potential with ever advancing high-throughput and novel technologies generating a wide-range of biomarker data, it is paramount that statistical methods be thoroughly evaluated and optimally implemented in translational research.

BSSI is on the cutting edge of Analytical R&D in the biomarker statistics space with active industry and academic collaborations as well as our own internal efforts.

The Complete Analytical Solution

  • Strategic planning
  • Statistical Analysis Plan (SAP) development
  • Program creation and validation
  • High quality reporting (SARs, CSRs, presentations)
  • Collaboration and integration with cross-functional teams

Extensive Experience

BSSI is experienced in biomarker analysis on Phase I-III clinical trials, post-marketing studies and non-clinical studies across therapeutic areas and assay platforms:


  • Genome-wide SNP genotyping
  • Candidate gene SNP genotyping
  • Sequencing (NGS, exome, Sanger)
  • Gene expression (arrays, qPCR, RNAseq)
  • Immunohistochemistry (IHC)
  • Protein Immunoassays
  • Copy Number (arrays, FISH)
  • New Technologies


[threecol_one_last]Biomarker Statistics services at BioStat Solutions

[box type=”info” style=”rounded”]View Our Hot Topic Areas of Research[/box] [box type=”info” style=”rounded”]Download BSSI’s white paper on Biomarker Discovery and Evaluation: Key Steps in the Development of a Tailored Analytical Strategy.[/box] [/threecol_one_last]