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Biostatistics and Data Analysis

Make confident decisions with analysis regulators trust

BioBoston provides senior biostatistics and data analytics support across study design, analysis, and reporting so your results are clear, defensible, and ready for FDA/EMA/ICH expectations.

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  • Senior biostatisticians and data leads
  • Clinical, preclinical, and real-world data support
  • Submission-ready outputs (tables, listings, figures, reports)
  • Flexible support: surge help or full-program

Who this is for

This service is a fit if

  • You need an expert to strengthen protocol design, endpoints, and statistical approach
  • You have messy data and need it cleaned, validated, and analysis-ready
  • You need fast, accurate analysis for an internal decision, investor update, or milestone
  • You’re preparing for a regulatory submission and need compliant outputs
  • Your team is overloaded and needs senior support without hiring full-time
  • Stronger data integrity and computer system controls where applicable

What you’ll get

  • You will receive clear, actionable, and audit-ready deliverables such as:
  • Statistical input to protocol design (endpoints, assumptions, sample size)
  • Analysis plan support (SAP-style structure aligned to your study stage)
  • Clean, analysis-ready datasets with documented checks
  • Statistical analyses with interpretation that leadership can use
  • Publication or submission-ready outputs (TFLs, summaries, and narratives as needed)
  • A clear “so what” decision summary (what the data means, risks, next steps)

What we do

Our biostatistics and data analytics support can include:

  • Study design and statistical consultation
  • Sample size and power calculations
  • Data management and cleaning (quality checks, queries, traceability)
  • Statistical modeling and analysis (appropriate methods based on your endpoints)
  • Clinical trial biostatistics support (interim and final analyses)
  • Regulatory submission support (analysis summaries, statistical sections, responses)
  • Real-world evidence and post-market analytics (trend monitoring, safety signals, outcomes)

Why BioBoston

  • Senior expertise, not generic analytics.
  • We understand life sciences decision pressure: timelines, regulators, and high stakes.
  • We balance scientific rigor with speed so you get analysis that is both timely and defensible.
  • We plug into your team easily and reduce rework by aligning outputs to the end goal early (submission, publication, or go/no-go decision).

Plan +
resourcing

We confirm scope, deliverables, and timelines, then assign the right senior biostats/data lead.

Execute + communicate

We analyze, quality-check, and deliver results with clear interpretation and next-step recommendations.

30-minute discovery call

We clarify your data sources, study stage, deadlines, and the decisions you need to make.

How it works

Frequently Asked Questions

Yes. We support preclinical research, clinical trials, and real-world evidence depending on your needs.

Yes. We can help organize, clean, and validate datasets and define a practical workflow.

Yes. We deliver compliant analyses and reporting aligned to FDA/EMA/ICH expectations and your submission strategy.

Turn your data into decisions you can stand behind

Free Consultation
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