Clinical Development Statistical Strategy
Statistical consulting for clinical development: objectives, endpoints, populations, design options and evidence-generation strategy.
Algoria Biometrics
Biostatistics, Programming & Clinical Data
A catalogue built around clinical and scientific work: choosing a design, producing results, reviewing vendors and integrating data and tools. Select the capability your team needs; we will agree owners, deliverables and acceptance criteria.
One working approach, different scopes
We combine statistical judgement, SAS/R programming and clinical data expertise. Experience spans clinical and translational research, vaccine studies, CRO collaboration and academic teams. Engage a defined deliverable, independent review or agreed senior allocation.
Experience settings include oncology, autoimmune and rare diseases, vaccines and infectious diseases, public health, pain, anaesthesia, critical care and patient-reported outcomes. Each indication's requirements are assessed with the clinical team.
Study design and statistical strategy
Statistical Analysis Plan Development
SAP authorship and updates for clinical studies: endpoints, estimands, populations, methods, sensitivity analyses and output specifications.
Study Design, Sample Size & Power
Statistical study design, sample size and power analysis for biomedical research, with documented scenarios, simulation, sampling and randomisation planning.
Trial Feasibility & Enrolment Scenarios
Data and assumption assessment for trial feasibility: eligibility, populations, follow-up and enrolment scenarios subject to validation.
Applied Statistics for Business: Project Assessment
Feasibility assessment for demand forecasting, segmentation and statistical process control: data requirements, validation and analytical scope for businesses.
Clinical programming and CDISC
CDISC SDTM & ADaM Dataset Programming
SDTM and ADaM preparation, transformation and review: mapping, derivations, metadata, QC and traceability between source data, SAP and outputs.
SAS & R Statistical Programming and TLF Delivery
Clinical trial tables, listings and figures with production and QC in SAS and R: shells, derivations, safety, efficacy, interim and final reporting.
SAS–R Modernisation & Programming Libraries
Modernise SAS macros and R workflows with reusable functions, TLF templates, QC automation, documentation and equivalence checks.
Oversight and technical leadership
CRO & Statistical Programming Oversight
Senior CRO oversight for clinical programming: SAP, SDTM/ADaM, TLF, QC, traceability, issue resolution and external deliverable coordination.
Interim Analysis & DSMB/DMC Statistical Support
Interim analysis and DSMB/DMC statistical packages: data cuts, TLF programming, QC and traceability under defined access and review rules.
Fractional Biostatistics & Programming Leadership
Statistical study lead and programming lead support by project or agreed allocation: technical coordination, prioritisation, senior review and mentoring.
Clinical analytics and evidence
Biomedical Statistical Analysis
Reproducible statistical analysis for clinical studies, cohorts and registries, including longitudinal models, survival, missing data and scientific reporting.
Longitudinal, Survival & Sensitivity Analysis
Repeated-measures, mixed-effects and time-to-event analysis for clinical studies: covariates, censoring, missingness and sensitivity.
RWE & Intervention Effect Analysis
Observational, post-marketing, pragmatic and before-after study analysis: adherence, outcomes, covariate adjustment and sensitivity.
Predictive Models & Patient Stratification
Predictive modelling, responder profiling and clinical stratification: regression, classification, clustering, validation, discrimination and calibration.
Clinical Technology & Patient-Reported Outcome Evaluation
Statistical support for clinical technologies, procedures, PROMs and repeated symptoms: design, outcomes, comparison and interpretation.
Vaccines, assays and biomarkers
Vaccine & Immunogenicity Biostatistics
Analysis and reporting for vaccine studies and immunogenicity data: SAPs, clinical/laboratory integration, longitudinal response and QC.
Assay Validation, Stability & Reproducibility Statistics
Statistical support for clinical laboratory assays: variability, reproducibility, stability, validation design and evaluation criteria.
Bioinformatics & Omics Data Analysis
Omics analysis consulting for bulk RNA-seq, single-cell, proteomics, metabolomics and clinical integration, with defined preprocessing and delivery scope.
Data platforms and scientific software
Clinical Data Platforms & Analytical Integration
Clinical and biomarker data integration with R, Python, SQL and Databricks: data models, pipelines, QC, lineage and analytical applications.
Scientific Software, Dashboards & Automation
Reproducible R and Python pipelines, analytical applications and dashboards for biomedical research, quality checks and scientific reporting.
Research Data Preparation & CRF Design
Research database cleaning and coding, data dictionaries and case report form design with traceable validation rules and analysis-ready transformations.
Research, publication and training
Statistical Manuscript Review & Reviewer Responses
Statistical review of biomedical manuscripts, methods, results and tables, with focused support for journal reviewer responses and analysis corrections.
Statistical Consulting for PhD Research
Statistical support for biomedical PhD research: study design, data preparation, reproducible analysis and interpretation with the research team.
Research Proposal Review & R&D Collaboration
Statistical and methodological review of research proposals: objectives, endpoints, sample size, feasibility and analysis plans for biomedical R&D.
Biostatistics & R Training for Biomedical Teams
Tailored biostatistics, R and reproducible analysis training for researchers and biomedical teams, with practical workshops matched to objectives and experience.
Focused diagnostic and review engagements
For an urgent decision or a bounded review, these engagements provide a focused starting point with defined inputs and deliverables.
Study Rescue Diagnostic
Rapidly identify statistical, programming and execution risks in a study under pressure.
Submission Readiness Pre-Audit
Find evidence and traceability gaps before CSR, audit, due diligence or submission.
SAP & Estimand Risk Review
Identify statistical, estimand and analysis risks before finalisation or regulatory review.
RWE / Observational Data Fitness Sprint
Determine whether observational data can credibly answer the research question before full analysis.
Translational, Biomarker & Immunogenicity Analytics
Turn complex assay and clinical data into reproducible, decision-ready analysis.
QC Automation & Clinical Review Dashboards
Reduce manual review with traceable checks, focused dashboards and reproducible workflows.
Discuss your project
Describe the objective, study stage and deadline. We will confirm fit, deliverables, timing and a quote based on complexity and data quality.
Do not email patient, clinical or confidential study data. Access and the working environment are agreed before materials are shared.
Discuss your project