About the job Remote | Clinical Biostatistician (SDTM, ADaM & TLF) - $110-$160/hour We are sharing a specialised part-time consulting opportunity for experienced clinical biostatisticians with strong expertise in Phase I-III clinical trials, SDTM and ADaM datasets, TLF production, and end-to-end statistical analysis workflows. This role supports advanced clinical research workflows involving realistic patient-level data generation and transformation from raw clinical data through SDTM and ADaM to final tables, listings, and figures. Selected experts will ensure that statistical outputs remain internally consistent, traceable to source data, and aligned with an existing Statistical Analysis Plan. Key Responsibilities Clinical Data Generation Generate realistic synthetic patient-level clinical trial data Develop data reflecting plausible patient populations, treatment patterns, outcomes, and study events Ensure generated datasets are clinically and statistically credible Maintain consistency across raw data, derived variables, analyses, and final reporting outputs Identify unrealistic or internally inconsistent data patterns SDTM Data Transformation Transform source clinical data into SDTM-compliant datasets Apply appropriate domain structures, variables, controlled terminology, and conventions Review datasets for completeness, consistency, and traceability Identify mapping or transformation issues that could affect downstream analyses Ensure patient-level information remains accurately represented across domains ADaM Dataset Development Develop ADaM datasets from SDTM and supporting source data Apply analysis derivations based on an existing Statistical Analysis Plan Ensure analysis populations, endpoints, baseline definitions, and derived variables are implemented correctly Maintain traceability between SDTM data, analysis datasets, and reporting outputs Review derivations for statistical and programming consistency Tables, Listings & Figures Produce and validate TLF outputs for clinical trial analyses Ensure tables, listings, and figures reconcile to their underlying ADaM and source datasets Review denominators, patient counts, summary statistics, and treatment-group outputs Identify inconsistencies between patient-level records and aggregate results Ensure every reported figure can be traced back through the analysis pipeline Statistical Analysis Execution Translate an existing Statistical Analysis Plan (SAP) into executable data transformations and analyses Implement planned endpoints, analysis populations, statistical methods, and reporting conventions Execute end-to-end analysis workflows across clinical trial datasets Validate results for statistical accuracy and internal consistency Apply experienced biostatistical judgement when interpreting ambiguous or complex specifications Cross-Layer Reconciliation Verify consistency across raw data, SDTM, ADaM, and TLF layers Confirm that patient-level events and measurements propagate correctly into final outputs Identify discrepancies introduced during transformation or derivation Review data lineage and traceability across the full analysis pipeline Ensure final outputs remain reconcilable to their underlying source data Task & Reference Output Development Design realistic biostatistics and clinical-data analysis assignments Develop clear task instructions and expected deliverables Produce authoritative reference outputs for statistical workflows Define objective criteria for accuracy, traceability, statistical validity, and completeness Create tasks that reflect authentic Phase I-III biostatistics practice Ideal Profile 5+ years of professional biostatistics experience , with 10-25 years preferred Hands-on experience across SDTM, ADaM, and TLF workflows Demonstrated experience supporting pre-market Phase I-III clinical trials Strong ability to translate an existing SAP into data transformations, analysis datasets, and reporting outputs Experience producing and validating patient-level clinical data and statistical outputs Strong understanding of dataset traceability and reconciliation across the clinical analysis lifecycle Ability to generate synthetic clinical data that is realistic and internally consistent Master's degree in Biostatistics or Statistics required PhD in Biostatistics, Statistics, or a closely related field preferred Strong statistical judgement and attention to analytical detail Excellent written communication and ability to document complex analysis workflows clearly Based in the United States, Canada, or France Engagement Details Part-time independent contractor engagement Fully remote Minimum availability of approximately 20-25 hours per week Availability of 30+ hours per week is preferred Flexible scheduling based on project requirements

Compensation:

$110-$160/hour Work may include synthetic clinical data generation, SDTM and ADaM transformation, TLF production, statistical analysis, and task development The role focuses on executing an existing SAP rather than authoring the SAP itself Projects may be extended, shortened, or concluded based on project needs and performance Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third party H1-B and

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