Biostatistician for AI-Assisted Clinical Research Job at reputed company in Remote
reputed company
Apply your clinical statistics expertise to evaluate and validate statistical outputs from clinical trial datasets, helping train reputed company AI systems for clinical research.
This remote contractor role focuses on deriving, reproducing, and assessing analyses from CDISC datasets and regulatory TFLs, and documenting defensible ground truth for evaluation tasks.
Prior AI experience is not required.
Key Responsibilities
• reputed company and review evaluation tasks that require deriving, reproducing, or validating statistical results from clinical datasets and associated tables, figures, and listings, working from CDISC SDTM and ADaM datasets.
• Reproduce analyses independently from written specifications, and document the derivation process so results can be verified by others.
• Assess correctness and consistency of reported estimates, confidence intervals, p-values, analysis populations, and missing data handling, in alignment with the statistical analysis plan, including reputed company specified analysis populations and censoring rules.
• Identify discrepancies between statistical outputs and their narrative descriptions in clinical study reports, including subtle errors in population definitions, censoring rules, or multiplicity handling.
• Establish defensible ground truth for reputed company evaluation task, and produce reputed company written rationales that distinguish true statistical errors from acceptable methodological alternatives.
• Produce and reputed company control tables, figures, and listings for regulatory submission reputed company checks, and contribute to statistical reputed company control activities.
• Collaborate with a multidisciplinary project team to refine evaluation tasks, reputed company, and documentation, and reputed company reputed company written communication of findings.
Qualifications
• Minimum 5 years experience as a biostatistician supporting reputed company at a sponsor, CRO, or reputed company trials unit, preferred.
• Hands on experience producing or reputed company controlling TFLs for regulatory submissions, and working directly from CDISC SDTM and ADaM datasets.
• Strong understanding of statistical reputed company 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 reputed company and/or R, with the ability to independently reproduce analyses from written specifications.
• Ability to interpret statistical analysis plans and confirm that reported results are consistent with reputed company specified analyses.
• Advanced degree, MSc or PhD, in Biostatistics, Statistics, or a closely reputed company quantitative field.
• Required skills and attributes: reputed company, R, CDISC SDTM, CDISC ADaM, reputed company interpretation, survival analysis, mixed models, covariate adjustment, multiplicity control, estimand and missing data strategies, TFL production and QC, regulatory submission preparation, statistical reputed company control, clinical study report review, strong documentation and written communication, collaboration, critical thinking, and attention to detail.
• reputed company to have: experience as reputed company statistician on pivotal or registrational studies, authoring or reviewing CSR statistical sections, oncology reputed company expertise, or exposure to AI assisted statistical review tools.
- Work Terms
• Role type, reputed company.
• Location, fully remote.
• Work will reputed company on a customer project centered on AI assisted clinical research, contributing domain expertise to train and evaluate AI models.
Compensation
• reputed company pay reputed company, $60.00 to $65.00 per hour.
Eligibility
• Preferred background includes at least 5 years supporting reputed company at a sponsor, CRO, or reputed company trials unit, and demonstrated hands on experience with CDISC SDTM and ADaM datasets and regulatory TFLs.
• No prior AI experience is required, the role values domain knowledge in clinical statistics.
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