Remote | Biostatistician — $60–$65/hour

We are sharing a specialised consulting opportunity for experienced Biostatisticians with strong expertise in clinical-trial statistics, SAS and R, CDISC SDTM/ADaM, Statistical Analysis Plan interpretation, TFL production and quality control, survival analysis, mixed models, estimands, and regulatory statistical review to contribute to an advanced AI training and clinical-research evaluation project.

Selected professionals will reproduce and validate statistical outputs from clinical datasets, assess consistency between analyses and Statistical Analysis Plans, review tables, figures, listings, and Clinical Study Reports, and establish defensible statistical ground truth for evaluation tasks. The work requires strong clinical-trial experience, rigorous statistical judgement, and clear documentation of analytical reasoning. No prior experience in AI is required.

Key Responsibilities

Clinical Trial Statistical Evaluation

• Author and review evaluation tasks involving clinical-trial statistics
• Derive, reproduce, and validate statistical outputs from clinical datasets
• Assess the accuracy of estimates, confidence intervals, p-values, and analysis populations
• Review statistical results against pre-specified analytical requirements
• Apply strong professional judgement to complex quantitative scenarios

TFL Production & Quality Control

• Review and reproduce tables, figures, and listings
• Perform statistical quality control on TFL outputs
• Identify discrepancies between datasets, analyses, and reported results
• Validate output structure, calculations, and population definitions
• Support regulatory-quality standards for statistical deliverables

CDISC SDTM & ADaM Analysis

• Work directly with CDISC SDTM and ADaM datasets
• Interpret analysis-ready datasets and derivation logic
• Validate variable definitions and analysis populations
• Trace reported outputs back to underlying clinical data
• Identify inconsistencies between dataset structure and statistical results

Statistical Analysis Plan Interpretation

• Interpret Statistical Analysis Plans and associated specifications
• Determine whether reported analyses follow pre-specified methods
• Assess population definitions, endpoint handling, and analytical assumptions
• Identify deviations from planned analyses
• Distinguish material statistical errors from acceptable methodological alternatives

Advanced Statistical Methods

• Apply survival-analysis methods in clinical-trial settings
• Evaluate mixed-model analyses and longitudinal data methods
• Assess covariate-adjustment strategies
• Review multiplicity-control approaches
• Evaluate estimand frameworks and missing-data strategies under ICH E9(R1)
• Assess censoring rules and endpoint-specific analytical assumptions

Clinical Study Report Review

• Review statistical sections of Clinical Study Reports
• Compare narrative conclusions against underlying statistical outputs
• Identify inconsistencies involving estimates, populations, censoring, or multiplicity
• Evaluate whether interpretations accurately reflect the statistical evidence
• Flag subtle analytical discrepancies that may affect regulatory conclusions

Ground Truth & Statistical Documentation

• Establish defensible ground truth for evaluation tasks
• Document derivation and validation methodology clearly
• Create reproducible analysis paths supporting independent verification
• Explain statistical conclusions in concise professional language
• Maintain detailed documentation of assumptions, methods, and findings

Regulatory Statistical Quality Assurance

• Support statistical review relevant to regulatory submissions
• Evaluate outputs for methodological and reporting consistency
• Identify statistical risks affecting submission-quality documentation
• Apply appropriate quality-control standards across clinical analyses
• Contribute to robust evaluation criteria for statistical-review tasks

Ideal Profile

• 5+ years of experience as a biostatistician supporting clinical trials
• Experience working at a sponsor, CRO, academic trials unit, or comparable clinical-research organisation
• Hands-on experience producing or quality controlling TFLs for regulatory submissions
• Direct experience working with CDISC SDTM and ADaM datasets
• Strong proficiency in SAS and/or R
• Ability to reproduce statistical analyses independently from written specifications
• Strong understanding of confirmatory clinical-trial methodology
• Experience with survival analysis and mixed models
• Familiarity with covariate adjustment and multiplicity control
• Strong knowledge of estimand and missing-data strategies under ICH E9(R1)
• Demonstrated ability to interpret Statistical Analysis Plans
• Experience reviewing Clinical Study Reports or statistical sections is highly valuable
• Strong statistical quality-control and documentation skills
• Excellent written communication ability
• Strong critical-thinking and analytical judgement
• Exceptional attention to detail
• MSc or PhD in Biostatistics, Statistics, or a closely related quantitative discipline
• Lead-statistician experience on pivotal or registrational studies is advantageous
• Oncology endpoint expertise is beneficial
• Exposure to AI-assisted statistical-review tools is a plus but not required
• No prior AI-training or model-evaluation experience is required

Engagement Details

• Independent contractor engagement
• Fully remote
• Compensation: $60–$65/hour
• Work will involve clinical-trial statistical analysis, CDISC SDTM/ADaM review, SAP interpretation, TFL validation, statistical quality control, CSR review, and regulatory statistical evaluation
• Strong SAS and/or R proficiency and clinical-trial statistical judgement are central to this engagement
• Assignments may involve clinical datasets, TFLs, SAPs, CSRs, analysis specifications, and structured statistical-evaluation tasks
• Work may require independently reproducing analyses and documenting derivations for verification
• Project scope, workload, therapeutic areas, datasets, and evaluation standards may evolve depending on project requirements
• Work must be completed without using confidential, proprietary, or identifiable patient information belonging to any employer, sponsor, CRO, healthcare organisation, research institution, patient, or other third party

About the Platform

This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.

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