Service
Biostatistics
Statistical design and analysis that is pre-specified, reproducible and clearly explained.
Overview
Good statistics begins with a clear question. We help teams translate objectives and estimands into a pre-specified analysis plan, and then execute that plan transparently.
We write for two audiences at once: the regulator who needs rigor, and the clinician who needs to understand what the numbers mean.
Standards & frameworks we work within
- ICH E9 and E9(R1) estimands framework
- ICH E3 report structure
- CONSORT reporting principles
- Applicable FDA / EMA statistical guidance
These are frameworks we work within or align to. They do not imply certification, accreditation or endorsement.
What we deliver
- Sample size and power considerations
- Statistical analysis plan authoring and review
- Randomisation specification support
- Interim, primary and exploratory analyses
- Survival, longitudinal and categorical data methods
- Statistical sections of protocols and reports
Typical deliverables
- Statistical Analysis Plan
- Analysis results and statistical output
- Statistical methods text for reports
- Reproducible analysis documentation
How we present results
Examples of our presentation style, using invented data.
Engagement models
Project-based
A defined scope, timeline and set of deliverables agreed up front.
Dedicated capacity
Specialists embedded in your workflow on a longer-term, scalable basis.
Advisory & ad hoc
Targeted expert input, reviews or surge support when you need it.
Frequently asked questions
Service descriptions are general and informational. Scope, responsibilities and outputs are defined in a written agreement for each engagement.
Explore other services in the services overview.
Discuss biostatistics
Tell us about your programme. We’ll respond with an honest view of how we can help, and where we can’t.