Clinical Biostatistician – SDTM, ADaM, TLF

This is a fully remote position, open to applicants in United States, +3 more locations.

📋 Description

• Generate realistic synthetic clinical trial data at the patient level.

• Create clinically and statistically valid datasets that represent feasible populations, treatment patterns, outcomes, and study events.

• Ensure consistency among raw data, derived variables, analyses, and final reporting outputs.

• Convert source clinical data into SDTM-compliant datasets.

• Utilize appropriate domain structures, variables, controlled terminology, and conventions.

• Develop ADaM datasets from SDTM and relevant source data using analysis derivations from an existing SAP.

• Correctly implement analysis populations, endpoints, baseline definitions, and derived variables.

• Generate and validate tables, listings, and figures for clinical trial analyses.

• Reconcile TLF outputs with the underlying ADaM and source datasets.

• Transform an existing SAP into actionable data transformations and analyses.

• Execute and verify end-to-end analysis workflows across clinical trial datasets.

• Ensure consistency across raw data, SDTM, ADaM, and TLF layers.

• Review data lineage and traceability throughout the entire analysis pipeline.

• Design biostatistics and clinical data analysis tasks.

• Create task instructions, expected deliverables, and authoritative reference outputs.

• Establish objective criteria for accuracy, traceability, statistical validity, and completeness.

⛳️ Requirements

• A minimum of 5 years of professional experience in biostatistics; 10–25 years preferred.

• Practical experience in SDTM, ADaM, and TLF workflows.

• Proven experience in supporting pre-market Phase I–III clinical trials.

• Capability to translate an existing SAP into data transformations, analysis datasets, and reporting outputs.

• Experience in producing and validating patient-level clinical data and statistical outputs.

• Strong understanding of dataset traceability and reconciliation throughout the clinical analysis lifecycle.

• Ability to generate synthetic clinical data that is both realistic and internally consistent.

• A Master’s degree in Biostatistics or Statistics is required.

• A PhD in Biostatistics, Statistics, or a closely related discipline is preferred.

• Exceptional statistical judgment and meticulous attention to analytical detail.

• Excellent written communication skills with the ability to document complex analysis workflows clearly.

• Must reside in the United States, Canada, or France.

• Availability of approximately 20–25 hours per week is required.

• Work must be conducted without using any confidential or proprietary information from any employer, sponsor, client, institution, or other third parties.

• H1-B and STEM OPT support is not available for this position.

🏝️ Benefits

• Engagement as a part-time independent contractor.

• Fully remote work arrangement.

• Flexible scheduling based on project needs.

• Project duration may vary based on requirements and performance.