- Author and review evaluation tasks for deriving, reproducing, or validating statistical outputs from clinical datasets.
- Assess correctness and consistency of reported estimates, confidence intervals, and p-values in alignment with SAP.
- Identify discrepancies between statistical outputs and narrative descriptions in clinical study reports.
- Establish defensible ground truth for evaluation tasks, documenting the derivation process for verification.
- Provide structured written rationales distinguishing true statistical errors from acceptable methodological alternatives.
- Collaborate with a multidisciplinary project team to refine evaluation tasks and criteria.
Requirements
- Have solid relevant experience in the domain supporting clinical trials at a sponsor, CRO,
or academic trials unit.
- Hands-on experience producing or quality controlling TFLs for regulatory submissions from CDISC SDTM/ADaM datasets.
- Solid understanding of statistical methods used in confirmatory trials, including survival analysis and mixed models.
- 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.
Application Process
- Easy Apply on LinkedIn
- Check email for next steps
- Participate in resume evaluation & interview stage