Quercus Data and Statistics ApS

Biostatistical Consulting for Biotech, Pharma, and Clinical Research

Expert biostatistical consulting for clinical trials—from study design to regulatory reporting.

I am Marc Andersen, an experienced biostatistician providing biostatistical consulting services to biotech and pharmaceutical companies since 2007. I support clinical development programs with high-quality statistical expertise, ensuring robust study design, regulatory compliance, and reliable data analysis.

Clinical Trial Biostatistics Services

I provide biostatistical support in the following areas:

• Clinical trial design and sample size calculation
• Development of trial protocols and Statistical Analysis Plans (SAPs)
• Interim and final statistical analyses for Clinical Study Reports (CSRs)
• Statistical oversight of clinical trials
• Statistical interpretation and data-driven insights for clinical development
• Quality control (QC) and independent review of statistical analyses and programming
• Review and validation of Tables, Figures, and Listings (TFLs) for regulatory submissions

Planning, Publications, and Market Access

I also support early-stage planning, regulatory interactions, and scientific communication:

• Literature reviews and evidence synthesis to inform study design and sample size
• Ad-hoc statistical analysis and programming to support regulatory interactions
• Statistical analysis, including Network Meta-Analysis (NMA), for scientific publications, HTA, and market access documentation