01 · Design and plan
Ground the study in a clear statistical approach.
Support protocol and sample-size review, statistical analysis plans, and mock shells in alignment with the study questions and planned outputs.
Clinical biometrics service
Clinical biostatistics services from study design to interpretation.
Connect study questions to appropriate design, analysis planning, statistical review, reporting, and scientific interpretation across clinical development.
Carry statistical intent from planning into analysis and review.
Gurus provides biostatistical expertise that connects study questions, appropriate methods, analysis planning, review, reporting, and interpretation. Responsibilities are shaped around the study stage, existing statistical strategy, available data, planned deliverables, and the wider clinical and programming team.
Core capabilities
- Protocol and sample-size review
- Statistical analysis plans and mock shells
- Randomization, interim analysis, and DMC support
- Statistical modeling, simulation, and exploratory analysis
- SDTM, ADaM, TLF, and CSR statistical review
- Integrated summaries, observational studies, and publications
Study lifecycle
Statistical support across the study lifecycle.
02 · Guide study analysis
Keep planned methods connected to study delivery.
Provide agreed support for randomization, interim analysis, DMC activities, statistical modeling, simulation, and exploratory analysis.
03 · Review and interpret
Connect datasets and outputs to the scientific story.
Review SDTM, ADaM, TLF, and CSR materials and support integrated summaries, observational studies, publications, and interpretation where scoped.
How Gurus fits
Statistical expertise integrated with the people doing the work.
Gurus can lead a defined statistical workstream or contribute within an established sponsor or CRO team. We align decision points, inputs, methods, review responsibilities, programming interfaces, deliverables, and communication paths with the study’s operating model.
Connected where it helps.
Keep biostatistics focused on a defined decision or workstream, or connect it with SAS and R programming and CDISC support for coordinated delivery.
Common questions
Clinical biostatistics FAQs.
Clear answers before we define the study-specific scope.
Which stages of a clinical study can Gurus biostatistics support?
Support can be scoped from protocol and sample-size review through statistical analysis planning, randomization, interim and DMC activities, analysis, statistical review, reporting, integrated summaries, observational studies, and publications.
What is the difference between biostatistics and statistical programming?
Biostatistics focuses on study questions, design, methods, analysis planning, review, and interpretation. Statistical programming implements agreed specifications in datasets, analyses, tables, listings, figures, and related documentation. Gurus can support either discipline or connect both.
Can Gurus support randomization, interim analysis, or DMC activities?
Yes, these activities are within the approved biostatistics capability set. The exact statistical responsibilities, independence requirements, access controls, deliverables, and interfaces are confirmed for each study.
Do you support observational studies and publications?
Yes. Gurus can provide statistical support for observational studies and publications, together with modeling, simulation, exploratory analysis, and interpretation when included in the agreed scope.
Your study, your operating model
Define the right biostatistics contribution.
Share the study stage, statistical questions, existing plans, decision points, required outputs, and team structure already in place.