Bio-Statistics and SAS

Our biostatistics and SAS teams support sponsors, CROs and research organisations with reliable, submission-ready outputs. We combine statistical rigour with practical experience across multiple therapeutic areas.

Overview

In clinical development, the quality of statistical analysis directly impacts decision making and regulatory outcomes. We provide biostatistics and SAS programming services that emphasise traceability, transparency and compliance, while remaining responsive to protocol amendments and evolving data needs.

Bio-Statistics and SAS

Study Design & Statistical Consultation

Support for protocol development, sample size estimation, randomisation schemes and statistical analysis plans (SAPs).

SAS Programming & Outputs

Creation and validation of SDTM/ADaM datasets, TLFs and custom listings, following sponsor standards and regulatory expectations.

Regulatory Submission Support

Preparation of documentation, outputs and responses required for health authority submissions and audits.

How We Work

Planning & Standards Alignment

We align on standards (CDISC, company-level templates) and define clear programming and review workflows.

Step 1

Programming & Validation

Biostatisticians and programmers collaborate to build, review and validate datasets and outputs using double-programming where appropriate.

Step 2

Ongoing Support & Updates

We handle protocol amendments, data refreshes and ad-hoc analyses while maintaining version control and documentation.

Step 3

Why This Matters

  • Submission-ready outputs that stand up to regulatory scrutiny.
  • Access to experienced biostatisticians and SAS programmers without expanding internal headcount.
  • Consistent adherence to CDISC and sponsor-specific standards.
  • Improved predictability of timelines and deliverables.

Need reliable statistical programming support for your next study or submission? Our teams can integrate seamlessly with your existing processes.

Talk to our team