Biostatistician

• Author and review evaluation tasks that require deriving, reproducing, or validating statistical outputs from clinical datasets and associated tables, figures, and listings (TFLs).
• Apply expert judgment to assess the correctness and consistency of reported estimates, confidence intervals, p-values, analysis populations, and missing data handling in alignment with the statistical analysis plan (SAP).
• Identify discrepancies between statistical outputs and their narrative descriptions in clinical study reports (CSR), including subtle errors in population definitions, censoring rules, or multiplicity handling.
• Establish defensible ground truth for each evaluation task, documenting the derivation process to enable independent verification.
• Provide structured written rationales distinguishing true statistical errors from acceptable methodological alternatives, employing clear and concise communication.
• Collaborate with a multidisciplinary project team, providing statistical insights and feedback as needed to refine evaluation tasks and criteria.

• No prior experience in AI is required — your domain knowledge is what matters.

• 5+ years as a biostatistician supporting clinical trials at a sponsor, CRO, or academic trials unit.
• Hands-on experience producing or quality controlling TFLs for regulatory submissions and working directly from CDISC SDTM/ADaM datasets.
• Solid 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 SAPs and ensure reported results are consistent with pre-specified analyses.
• Advanced degree (MSc or PhD) in Biostatistics, Statistics, or a closely related quantitative field.
• Experience as lead statistician on pivotal/registrational studies, authoring or reviewing CSR statistical sections, oncology endpoint expertise, and exposure to AI-assisted statistical review tools.

Also listed: written communication, collaboration, critical thinking, attention to detail.

Project and contracting process: micro1. Applications continue on the provider's website.