Remote | Biostatistician — $60–$65/hour at 24-MAG in New York, New York, United States

Job description

• 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 clinical-trial analyses, assess consistency with Statistical Analysis Plans, review TFLs and Clinical Study Reports, and establish defensible statistical ground truth for evaluation tasks. No prior experience in AI is required.

Responsibilities

• Clinical Trial Analysis & Validation
• Reproduce and validate statistical outputs from clinical datasets
• Assess estimates, confidence intervals, p-values, endpoints, and analysis populations
• Interpret Statistical Analysis Plans and determine whether analyses follow pre-specified methods
• Evaluate survival analyses, mixed models, covariate adjustment, multiplicity, censoring, and missing-data strategies
• Apply estimand principles under ICH E9(R1) and distinguish material errors from acceptable methodological alternatives
• CDISC, TFL & CSR Review
• Work directly with CDISC SDTM and ADaM datasets
• Validate derivation logic, variable definitions, and analysis populations
• Reproduce and quality-control tables, figures, and listings
• Trace reported results back to source datasets and analysis specifications
• Review CSR statistical sections for inconsistencies involving estimates, populations, censoring, multiplicity, or interpretation
• Statistical Ground Truth & Quality Assurance
• Establish defensible statistical ground truth for evaluation tasks
• Create reproducible analysis paths supporting independent verification
• Document assumptions, derivations, methods, and findings clearly
• Identify statistical or reporting issues affecting regulatory-quality deliverables
• Provide concise, structured feedback supporting robust evaluation standards

Requirements

• 5+ years of experience as a biostatistician supporting clinical trials
• Experience 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 with CDISC SDTM and ADaM datasets
• Strong proficiency in SAS and/or R
• Ability to independently reproduce statistical analyses from written specifications
• Strong knowledge of confirmatory trial methodology, survival analysis, and mixed models
• Familiarity with covariate adjustment, multiplicity control, estimands, and missing-data strategies under ICH E9(R1)
• Demonstrated experience interpreting Statistical Analysis Plans
• CSR or regulatory statistical-review experience is highly valuable
• 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
• No prior AI-training or model-evaluation experience is required

Skills

Required

• SAS
• R
• CDISC SDTM
• CDISC ADaM
• Statistical Analysis Plan interpretation
• TFL production and quality control
• Survival analysis
• Mixed models
• Estimands
• ICH E9(R1)
• Covariate adjustment
• Multiplicity control

Preferred

• CSR review
• Regulatory statistical review
• Lead-statistician experience
• Oncology endpoint expertise