Biostatistician for AI‑assisted Clinical Research Remote
Overview
A remote contractor role for a Biostatistician supporting an AI-assisted clinical research project at micro1. You will generate and validate statistical outputs from clinical datasets, review TFLs, and judge analysis quality against the SAP. The work informs how AI models learn from real-world data, with emphasis on accuracy and clear documentation. Expect collaboration with a cross‑disciplinary team and a strong focus on regulatory‑grade standards. CDISC SDTM/ADaM and survival analysis are central to the tasks performed.
What You'll Do6
- 1Derive, reproduce, or validate statistical outputs from clinical datasets, including tables, figures, and listings (TFLs).
- 2Assess the correctness and consistency of estimates, confidence intervals, p-values, analysis populations, and missing-data handling in line with the SAP.
- 3Identify discrepancies between statistical outputs and CSR narratives, including population definitions and censoring or multiplicity rules.
- 4Document the derivation process to establish defensible ground truth for each evaluation task so others can verify it.
- 5Provide clear written rationales that distinguish true statistical errors from acceptable methodological alternatives.
- 6Collaborate with a multidisciplinary team to refine evaluation tasks and criteria using statistical insights.
Requirements7
- 15+ years as a biostatistician supporting clinical trials in sponsor, CRO, or academic settings.
- 2Hands-on experience producing or quality controlling TFLs for regulatory submissions using CDISC SDTM/ADaM datasets.
- 3Strong grasp of confirmatory trial methods: survival analysis, mixed models, covariate adjustment, multiplicity control, and ICH E9(R1) estimand and missing-data strategies.
- 4Proficiency in SAS and/or R with the ability to reproduce analyses from written specifications.
- 5Ability to interpret SAPs and ensure reported results match predefined analyses.
- 6Advanced degree (MSc or PhD) in Biostatistics, Statistics, or a related quantitative field.
- 7Nice to have: lead statistician experience on pivotal studies, CSR statistical section experience, oncology endpoints, and exposure to AI-assisted statistical review tools.
Who Should Apply
The ideal candidate has substantial clinical trial statistics experience, especially with CDISC SDTM/ADaM data and regulatory deliverables. This role suits someone who can translate complex analyses into defensible, well-documented evidence and who thrives in a collaborative, evaluation-focused environment. It may be less suitable for those without deep experience in regulatory contexts or without SAS/R proficiency. Common fit issues include limited exposure to CDISC datasets or difficulty aligning SAP interpretations with CSR narratives.
Salary Insight
60 - 65 per hour. Pay terms discussed later during the hiring process.
Location
Required Skills
Application Tip
Highlight concrete regulatory experience: cite specific studies where you produced or QC’d TFLs from CDISC SDTM/ADaM, and mention a time you aligned SAP interpretations with CSR outputs.
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1Application received
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