Biostatistics | Magnus CRO

Strategic Biostatistics for Confident Decisions

Magnus CRO provides end-to-end biostatistics leadership—from early design and estimand strategy to validated deliverables ready for regulatory submission. We combine rigorous methodology, clear communication, and audit-ready documentation.

Study Design & Estimands

Endpoint strategy & estimands: Define population, variable, intercurrent event handling (treatment policy, hypothetical), and summary measure.
Design selection: Parallel-group, crossover, adaptive, enrichment, non-inferiority/equivalence.
Sample size & power: Assumption setting, sensitivity analyses, and attrition modeling.
Randomization: Stratification factors, block sizes, and IxRS/RTSM specifications.

SAP Authoring & Standards

Comprehensive Statistical Analysis Plan (SAP) with shell tables/listings/figures, analysis populations, and algorithmic rules.
Missing data strategy (MMRM, MI, tipping point), sensitivity analyses, and protocol deviations handling.
Multiplicity control (gatekeeping, Holm/Hochberg, alpha spending) aligned to objectives and endpoints.
CDISC-compliant specs (SDTM/ADaM) and traceability definitions.

Interim & Final Analyses

Interim monitoring: Boundaries via group sequential or alpha spending (O’Brien–Fleming, Pocock), DMC charters, and unblinded workflows.
Efficacy & safety: Time-to-event, mixed models, generalized linear models, repeated measures, and nonparametric methods as needed.
Subgroup & sensitivity: Pre-specified subgroup interaction, robustness checks, and tipping point assessments.
CSR support: Narrative guidance, integration with clinical sections, and result interpretation.

Deliverables & Traceability

ADaM datasets with end-to-end derivation rules and reviewer guides.
TLFs (tables, listings, figures) aligned to SAP shells and submission standards.
Data Reviewer’s Guide (ADRG) and Define-XML package with clear lineage from SDTM.
Regulatory Q&A support and responses to information requests.

Quality, Tools & Communication