Biostatistician (Clinical Output Validation)

What you'll do

This is the statistical reviewer's desk, rebuilt as AI evaluation. You author and review tasks that ask a model to derive, reproduce or validate statistical outputs from clinical datasets and their tables, figures and listings (TFLs). For each one you establish the defensible ground truth yourself and document how you got there, so another statistician could verify it independently.

The judgment calls are the ones any lead statistician on a submission makes. Are the estimates, confidence intervals and p-values right? Is the analysis population the one the statistical analysis plan (SAP) specified? Is missing data handled as pre-specified? And does the clinical study report (CSR) narrative actually match the output it describes? The ad singles out subtle errors: a population definition that has shifted, a censoring rule applied inconsistently, multiplicity handled differently from the plan.

Your written rationales have to separate a genuine statistical error from an acceptable methodological alternative, which is often the hardest line to draw. You also feed statistical input back to a multidisciplinary team refining the tasks and criteria.

Who fits

• 5+ years as a biostatistician on clinical trials at a sponsor, CRO or academic trials unit
• Hands-on production or QC of TFLs for regulatory submissions, working directly from CDISC SDTM and ADaM datasets
• Confirmatory-trial methods: survival analysis, mixed models, covariate adjustment, multiplicity control, and estimand and missing-data strategies under ICH E9(R1)
• SAS and/or R, well enough to reproduce analyses independently from written specifications
• Comfort reading SAPs and checking reported results against pre-specified analyses
• An MSc or PhD in biostatistics, statistics or a close quantitative field

Nice to have: lead statistician on pivotal or registrational studies, CSR statistical section authorship or review, oncology endpoint expertise, and exposure to AI-assisted statistical review tools.

What it pays

$60–65/hour, micro1's published band. It is narrow, so there is little doubt about the figure, but it is modest for a senior clinical statistician. The ad publishes no compensation structure, weekly hours or project length, so whether this is paid for time or per task is not stated.

How it differs from the other Biostatistician listing

micro1's other Biostatistician listing is a separate project at $60–100/hour, paid per accepted task, where you build benchmark tasks from scratch with 35+ item rubrics and source the data yourself. This one is closer to regulatory QC work: validating and reproducing outputs from existing CDISC datasets and TFLs against the SAP and CSR. The band here is narrower and lower, there are 30 openings rather than 50, and the experience ask is 5+ years rather than 4.

Worth knowing

Good:

• Directly uses TFL QC and SAP-compliance skills most trial statisticians already have
• Working from existing datasets means no hunting for authentic data
• 30 openings, flagged high demand
• A narrow, predictable band

Less good:

• $60–65 is low for the seniority asked, and below the ceiling of micro1's other biostatistics project
• No compensation structure, weekly hours or project length published
• Writing defensible rationales for every discrepancy is slow, careful work
• Contractor engagement: no benefits, your own tax to manage

About this listing

Posted by micro1 on its own jobs portal about two months before we read it on 24 September 2026. The $60–65/hour band, the 30 openings and the qualifications are its published text. Location is Remote with no country list, and the customer is not named. Payment schedule and method are not published on the listing. See micro1.