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BIOSTATISTICS SERVICES
BioBoston CRO provides biostatistics services for sponsors that need statistically defensible study planning, analysis specifications, programming support, and interpretation aligned with the clinical question and the planned use of the results. Support can begin during early development planning, protocol development, study execution, database-lock preparation, or reporting.
Global Reach
Therapeutic Area Coverage
Years of Experience
START A CONVERSATION
Select the support you need and share a few details about your project. We’ll use this information to route your inquiry to the appropriate BioBoston team member.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
SERVICES
Define the statistical framework that connects the clinical question, evidence objective, study design, endpoints, analysis populations, missing-data considerations, sensitivity analyses, and decision criteria.
Useful when program teams need to compare design options, prepare for regulatory discussion, or reconcile scientific ambition with sample size, feasibility, timing, and data limitations.
Develop and document sample-size assumptions, methods, scenarios, and sensitivity analyses using the available evidence and the intended study objective.
Useful when the team needs a transparent basis for planning, budget development, protocol review, feasibility assessment, or a design change.
Develop or review a Statistical Analysis Plan that defines analysis populations, variables, methods, handling of intercurrent events and missing data, multiplicity, sensitivity analyses, and output conventions.
Useful before database lock, during protocol development, or when an existing plan is incomplete, inconsistent, or difficult to implement.
Define randomization methodology, stratification, block or allocation considerations, masking controls, specifications, review steps, and documentation appropriate to the study design.
Useful when the sponsor needs independent design input, vendor specifications, validation review, or controlled handling of randomization materials.
Develop or review table, listing, and figure shells and output specifications so planned analyses, data presentations, and report narratives are aligned before programming begins.
Useful when teams need early output planning, consistent conventions, efficient review, or a clear bridge between the Statistical Analysis Plan and the Clinical Study Report.
Provide scoped programming, validation, quality-control, output generation, or independent review using sponsor-approved standards, specifications, data, and controlled processes.
Useful for a defined work package, temporary capacity, independent validation, or recovery of programming activities that are not progressing to plan.
Common Triggers
Desired outcomes
Make assumptions, tradeoffs, limitations, and decision criteria visible to clinical, regulatory, operational, and executive stakeholders.
Keep the protocol, data-management approach, Statistical Analysis Plan, shells, programs, and report interpretation connected.
Produce specifications and outputs that can be reviewed, challenged, reproduced, and approved through the sponsor's controlled process.
Identify statistical decisions and data dependencies early enough to prevent avoidable protocol, database, programming, or reporting rework.
RELATED SERVICES
Connect statistical design choices with the broader clinical development plan, endpoint strategy, evidence roadmap, and vendor-selection decisions.
Integrate approved statistical concepts into the complete protocol while maintaining clear ownership of scientific decisions and authoring.
Align data collection, edit checks, database design, reconciliation, and lock-readiness activities with the planned analyses.
Coordinate tables, listings, figures, analysis interpretation, and narrative development for the final study report.
Manage statistical milestones, cross-functional dependencies, vendor interfaces, decisions, and escalation across the study plan.
deliverables
Approach
A statistician should not work from isolated endpoints or a late programming request. BioBoston scopes the decision, intended use, source evidence, design maturity, data availability, timelines, review owners, and related document dependencies before defining the work package.
The sponsor and designated clinical, medical, regulatory, data, safety, and operational owners remain responsible for scientific and program decisions. Statistical support makes assumptions explicit, evaluates options, documents methods, and produces reviewable outputs for sponsor approval.
Process
1. Confirm the clinical question, study stage, decision or milestone, stakeholders, current documents, available data, and expected statistical role.
2. Review the design, endpoints, assumptions, source evidence, data flow, planned analyses, and known constraints; issue an open-item and risk list.
3. Develop the agreed strategy, calculation, analysis specification, randomization material, shell package, or programming plan.
4. Coordinate review with the designated clinical, regulatory, data-management, medical-writing, safety, and operational owners.
5. Resolve comments, perform the agreed statistical and programming quality controls, and document remaining limitations or dependencies.
6. Prepare the approved deliverables for protocol, database, vendor, submission, reporting, or archive handoff as defined in scope.
The right statistical support depends on the decision the study must inform, the maturity of the design, the quality of the available data, and the downstream regulatory or operational use.
Translate clinical questions and evidence needs into a statistical strategy before the protocol, budget, and vendor plan become difficult to change.
Align objectives, endpoints, sample size, randomization, analysis populations, and data collection before study start or a major amendment.
Finalize the Statistical Analysis Plan, shells, programming approach, quality controls, and interpretation path before database lock and report writing.
Expertise
Statistical experience should match the study design, therapeutic or product context, development stage, endpoint type, data structure, intended regulatory use, and required programming environment. Present the assigned statistician or programmer through an approved profile that identifies relevant experience without overstating outcomes.
PRACTICAL GUIDANCE
A planned guide to clinical relevance, variability, event rates, dropout, scenarios, and traceable planning assumptions.
A planned checklist for protocol alignment, populations, endpoints, methods, missing data, multiplicity, outputs, and quality control.
A planned article explaining how early output planning improves programming, review, and Clinical Study Report development.
FAQs
Engage statistical support before key design and endpoint decisions are locked, and again before the Statistical Analysis Plan, database lock, programming, and report interpretation milestones. Earlier involvement usually makes assumptions and tradeoffs easier to address.
Yes. An independent review can focus on design assumptions, sample size, protocol language, the Statistical Analysis Plan, randomization specifications, output shells, programs, validation evidence, or interpretation. The review criteria and access to source materials should be defined at kickoff.
Yes. Statistical Programming is an approved section of the Tier 1 Biostatistics page. It may be scoped as programming execution, validation, quality control, output generation, specification review, or temporary capacity, subject to confirmation of the required software and standards.
Useful inputs include the study objective, endpoint, analysis method, clinically meaningful effect, variability or event-rate assumptions, allocation, power, significance level, dropout, design features, prior evidence, and operational constraints.
The protocol describes the study design and high-level analysis approach. The Statistical Analysis Plan provides the detailed, implementation-ready definitions and methods required to analyze the data consistently. The two documents should align but serve different purposes.
Yes. A focused review can assess assumptions, methods, consistency, traceability, reproducibility, output accuracy, or interpretation without transferring sponsor decision authority.
PROJECT FORM
Share the study stage, design, endpoints, available documents or data, target milestone, and the type of statistical support you need. A BioBoston team member will review the request and follow up regarding fit and possible next steps.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
A productive first discussion starts with the clinical question, the decision the study must support, the assumptions already made, and the next milestone. BioBoston can then identify the appropriate statistical role, work package, review model, and cross-functional dependencies.
