Statistical strategy and SAPs
Draft and review statistical analysis plans, endpoint definitions, mock TFL shells, and programming specifications aligned with protocols and regulatory objectives.
Clinical trial statistics · SAS programming · Billionmatrix.com
Regulatory-ready statistics for clinical development teams.
Billion Matrix Consulting LLC provides biostatistics consulting and SAS statistical programming grounded in 9+ years of experience supporting clinical trials, regulatory submissions, and cross-functional development decisions for biopharma teams.
analysis matrix
v1.0
Oncology survival analysis
Advanced Methods
IPCW · MaxCombo · crossover
95% CI
1.12 - 1.46
reproducible
privacy-aware
documented
9+ years in clinical trials
Statistical analysis and SAS statistical programming across oncology, dermatology, and inflammatory conditions.
Regulatory-ready deliverables
Submission-ready TFLs, statistical analysis plans, ISS/ISE support, and responses to agency questions.
Advanced survival methods
Weighted log-rank, piecewise log-rank, RMST, IPCW, two-stage methods, and simulation-based planning.
Services
Clinical statistics support from protocol questions to submission-ready outputs.
Clinical trial analyses
Support oncology, hematology, dermatology, and inflammatory-condition studies with survival, longitudinal, safety, efficacy, exposure-response, and ad hoc analyses.
TFL production and QC
Produce and independently validate tables, listings, and figures for DMCs, CSRs, eCTD modules, label updates, conference materials, and publication support.
Simulation and workflow automation
Apply Monte Carlo simulation, bootstrapping, event accrual forecasting, and AI-assisted validation tools to stress-test designs and streamline dashboards and reporting workflows.
Healthcare teams we support
Built for biopharma teams where statistical details become regulatory decisions.
Billion Matrix works best with sponsors and clinical development teams that need a statistics partner who can move between protocols, data standards, medical interpretation, programming details, and agency-facing deliverables.
Oncology and hematology programs
Dermatology clinical teams
Inflammatory-condition studies
Regulatory submission teams
DMC and conference teams
Clinical, commercial, and publication partners
Consulting process
A clinical-trial workflow for analyses that need to withstand review.
Clarify endpoint and strategy
Translate protocol questions into estimands, endpoint definitions, analysis populations, and SAP language.
Specify outputs
Create mock TFL shells, programming specifications, and QC expectations before analysis begins.
Analyze and stress-test
Apply appropriate models, sensitivity analyses, survival methods, resampling, and simulation checks.
Deliver and defend
Package validated outputs for CSRs, eCTD modules, DMC review, label updates, publications, and team decisions.
Regulatory-aware workflow
Analysis that can be explained, reviewed, and repeated.
Global submission experience. Work reflects experience supporting FDA, EMA, and PMDA submissions, label updates, and health authority questions across multiple regions.
Independent programming and QC. TFLs, ADaM reviews, vendor outputs, and in-house analyses are checked with traceable SAS, R, and statistical review practices.
Cross-functional communication. Statistical results are prepared for clinicians, medical writers, pharmacovigilance, data management, commercial partners, and publication teams.
Engagement models
Flexible support for project work, embedded teams, hiring transitions, and permanent roles.
Defined-scope consulting support
Bring in focused biostatistics, SAS programming, analysis, QC, or regulatory submission support for a specific study, milestone, or deliverable.
Start with delivery, then decide
Begin with a consulting engagement when the team needs immediate help and wants the option to transition into a longer-term role.
Functional Service Provider support
Embed biostatistics or statistical programming support into your operating model for ongoing clinical development needs, recurring deliverables, and cross-study continuity.
Long-term statistics talent
Support full-time hiring needs for biostatistics and statistical programming roles that require clinical trial judgment and regulatory-ready execution.
Contact
Bring a clinical trial question. Leave with a statistical path forward.
For SAP support, TFL QC, survival analysis, simulation, regulatory response work, or early scoping, contact Billion Matrix Consulting LLC.