Study Design and Biostatistics Collaboration for a Research Organisation

Context

A research organisation needed methodological and statistical collaboration on a scientific programme — study design and analysis support without transferring sponsorship, ethics accountability or publication ownership away from the institution.

Overview

We collaborated on clinical study / research design and biostatistics as scoped in the engagement, using tools and reporting conventions agreed with the local scientific team. The institution retained sponsorship, ethics accountability and publication ownership.

Approach

1. Discover scientific aims, constraints, data context and governance expectations
2. Frame advisory vs delivery scope; keep institutional ownership explicit in writing
3. Provide design input, analysis planning and statistical support as agreed
4. Hand over reproducible-minded outputs for local ownership and review

Our role

• Methodological and analytical collaborator under a scoped statement of work
• The institution remained sponsor and PI-led

What mattered

• Written owners with academic / institutional governance
• Design and analysis coherence before protocols or analysis plans hardened
• Handoff materials the local team could defend in internal review

Result

The institution received design and biostatistics deliverables agreed in the SOW, suitable for their internal scientific process.

Notes

• Published anonymously (T2); naming requires a separate publication checklist
• The institution retained scientific and ethics ownership

Related

Biostatistics · Clinical study design · Research organisations · How we work