Biostatistician

Role Title: Biostatistician Role Type: Contractor Location: Remote micro1 is engaging Biostatisticians to contribute their clinical statistics expertise to a dynamic customer project focused on AI-assisted clinical research. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required - your domain knowledge is what matters. Scope of Work • 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. Preferred Qualifications • 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. • Nice to have: 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. Originally posted on Himalayas