Biostatistician for AI-Assisted Clinical Research

Apply clinical biostatistics expertise to author, review, and validate evaluation tasks that train and evaluate AI-assisted clinical research systems. You will derive, reproduce, and confirm statistical outputs from clinical datasets and tables, figures, and listings, establish defensible ground truth for evaluations, and communicate clear, evidence-based rationales about statistical correctness and methodology.

• Author and review evaluation tasks that require deriving, reproducing, or validating statistical outputs from clinical datasets and associated TFLs, establishing reproducible ground truth for each task.
• Reproduce analyses independently from written specifications, verifying estimates, confidence intervals, p-values, and other reported statistics against source data and methods.
• Assess correctness and consistency of reported results with respect to the statistical analysis plan, including analysis populations, censoring rules, and missing-data handling.
• Identify discrepancies between statistical outputs and narrative descriptions in clinical study reports, including subtle errors in population definitions, multiplicity handling, or other method choices.
• Document derivation and verification processes so results can be independently checked, and provide structured written rationales distinguishing true statistical errors from acceptable methodological alternatives.
• Collaborate with a multidisciplinary project team to refine evaluation tasks, criteria, and documentation.

• Required technical skills, demonstrated: SAS, R, CDISC SDTM, CDISC ADaM, statistical analysis plan interpretation, survival analysis, mixed models, covariate adjustment, multiplicity control, estimand and missing-data strategies under ICH E9(R1), TFL production and quality control, regulatory submission preparation, statistical quality control, and clinical study report review.
• Proficiency in SAS and/or R with the ability to reproduce analyses from written specifications.
• Strong written communication, collaboration, critical thinking, and attention to detail.
• Advanced degree, MSc or PhD, in Biostatistics, Statistics, or a closely related quantitative field.
• Preferred, but not strictly required: 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit.
• Nice to have: experience as lead statistician on pivotal or registrational studies, authorship or review of CSR statistical sections, oncology endpoint expertise, or exposure to AI-assisted statistical review tools.

• Engagement type: Independent contractor.
• Location: Remote.
• Project focus: Contributing clinical-statistics subject matter expertise to a customer project aimed at AI-assisted clinical research, producing evaluation tasks and ground-truth documentation for model training and evaluation. No prior experience in AI is required, domain knowledge in clinical statistics is the priority.

Hourly rate: $60 to $65 per hour.

• Candidates must be able to work as independent contractors.
• Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM and ADaM datasets is expected for this role.
• Preference will be given to candidates with 5+ years supporting clinical trials at a sponsor, CRO, or academic trials unit, and with experience interpreting SAPs and ensuring reported results align with pre-specified analyses.

If you are interested in this opportunity, please follow the application instructions on the platform where this posting appears to express interest and submit your profile. Be prepared to document relevant trial experience and examples of work reproducing or verifying statistical results from clinical datasets and TFLs.