Biostatistician for AI-Assisted Clinical Research [Remote]

Apply your clinical statistics expertise to evaluate and validate statistical outputs from clinical trial datasets, helping train next generation AI systems for clinical research. This remote contractor role focuses on deriving, reproducing, and assessing analyses from CDISC datasets and regulatory TFLs, and documenting defensible ground truth for evaluation tasks. Prior AI experience is not required.

• Author and review evaluation tasks that require deriving, reproducing, or validating statistical results from clinical datasets and associated tables, figures, and listings, working from CDISC SDTM and ADaM datasets.
• Reproduce analyses independently from written specifications, and document the derivation process so results can be verified by others.
• Assess correctness and consistency of reported estimates, confidence intervals, p-values, analysis populations, and missing data handling, in alignment with the statistical analysis plan, including pre specified analysis populations and censoring rules.
• Identify discrepancies between statistical outputs and their narrative descriptions in clinical study reports, including subtle errors in population definitions, censoring rules, or multiplicity handling.
• Establish defensible ground truth for each evaluation task, and produce structured written rationales that distinguish true statistical errors from acceptable methodological alternatives.
• Produce and quality control tables, figures, and listings for regulatory submission quality checks, and contribute to statistical quality control activities.
• Collaborate with a multidisciplinary project team to refine evaluation tasks, criteria, and documentation, and provide clear written communication of findings.

• Minimum 5 years experience as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit, preferred.
• Hands on experience producing or quality controlling TFLs for regulatory submissions, and working directly from CDISC SDTM and ADaM datasets.
• Strong understanding of statistical methods used in confirmatory trials, including survival analysis, mixed models, covariate adjustment, multiplicity control, and estimand and missing data strategies under ICH E9(R1).
• Proficiency in SAS and/or R, with the ability to independently reproduce analyses from written specifications.
• Ability to interpret statistical analysis plans and confirm that reported results are consistent with pre specified analyses.
• Advanced degree, MSc or PhD, in Biostatistics, Statistics, or a closely related quantitative field.
• Required skills and attributes: SAS, R, CDISC SDTM, CDISC ADaM, SAP interpretation, survival analysis, mixed models, covariate adjustment, multiplicity control, estimand and missing data strategies, TFL production and QC, regulatory submission preparation, statistical quality control, clinical study report review, strong documentation and written communication, collaboration, critical thinking, and attention to detail.
• Nice to have: experience as lead statistician on pivotal or registrational studies, authoring or reviewing CSR statistical sections, oncology endpoint expertise, or exposure to AI assisted statistical review tools.

• Role type, independent contractor.
• Location, fully remote.
• Work will focus on a customer project centered on AI assisted clinical research, contributing domain expertise to train and evaluate AI models.

• Hourly pay range, $60.00 to $65.00 per hour.

• Preferred background includes at least 5 years supporting clinical trials at a sponsor, CRO, or academic trials unit, and demonstrated hands on experience with CDISC SDTM and ADaM datasets and regulatory TFLs.
• No prior AI experience is required, the role values domain knowledge in clinical statistics.