Clinical Biostatistician | $65/hr Remote

Role Responsibilities

• 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 strong 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.