CASE 03
Principal Biostatistics Rescue: Estimands & ICE
Rapid principal-level onboarding to restore methodological ownership and enable implementation of a complex estimand framework.
Case Overview
Why this case mattered
A statistical rescue driven by resource loss rather than poor underlying science. TUNECT entered when a CRO had lost key senior statistical capacity while the project still required advanced estimand and intercurrent-event implementation.
Principal-level
statistical ownership restored quickly
Sponsor retained
relationship stabilized through quality and communication
+2 Senior SAS
follow-on work expanded beyond biostatistics
The Challenge
What TUNECT walked into
Only a short window remained in the original plan. The programming team could not reliably implement the planned analyses without senior methodological guidance, while Sponsor dissatisfaction was increasing. The immediate need was to convert conceptual estimands into executable analysis logic and regain control of decision-making.
Our Approach
How the project was handled
01
Principal onboarding
Joined immediately at Principal level and aligned key methodological decisions with the CRO team.
02
ADaM specification ownership
Translated estimands and ICE strategies into explicit derivations, variables and edge-case rules that programmers could execute.
03
QC + Sponsor interface
Reviewed key datasets and TFLs, supported QC programming and participated in Sponsor discussions to stabilize confidence.
A rescue is not always about recovering the original timeline. Sometimes the correct objective is to establish a defensible path forward, communicate it clearly and protect the quality of the evidence.
Outcome
What changed
Methodological clarity
Complex estimand and ICE requirements were converted into operational analysis rules.
Quality preserved
Although the original schedule could not be fully recovered, output integrity and traceability were protected.
Partnership retained
Transparent communication reduced escalation pressure and the relationship continued into additional work.
Client, Sponsor and study identifiers are anonymized where needed.
Facing a similar challenge?
TUNECT can join as a project team, embedded FSP resource or independent specialist group depending on the study need.