Clinical Biostatistician – SDTM, ADaM, TLF

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🔥 0 minutes ago

🌐 United States, Canada, +1 more countries – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote 🇫🇷 France – Remote

🗽 New York – Remote

🗽 New York – Remote

💵 $110 - $160 / hour

⏱ Part Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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24-MAG

WebsiteLinkedInAll Job Openings

2 - 10 employees

🤝 B2B

💼 Consulting

B2B • Consulting

24-MAG is a commercial strategy and execution firm that helps B2B organizations design and implement systems, workflows, and operating rhythms for sales, client management, and cross-functional projects. They focus on transforming scattered processes into aligned, measurable, and scalable commercial functions—covering pipeline structure, account management frameworks, and operational discipline for teams seeking efficient, intentional growth.

📋 Description

• Generate realistic synthetic patient-level clinical trial data • Develop clinically and statistically credible datasets reflecting plausible populations, treatment patterns, outcomes, and study events • Maintain consistency across raw data, derived variables, analyses, and final reporting outputs • Transform source clinical data into SDTM-compliant datasets • Apply appropriate domain structures, variables, controlled terminology, and conventions • Develop ADaM datasets from SDTM and supporting source data using analysis derivations from an existing SAP • Implement analysis populations, endpoints, baseline definitions, and derived variables correctly • Produce and validate tables, listings, and figures for clinical trial analyses • Reconcile TLF outputs with underlying ADaM and source datasets • Translate an existing SAP into executable data transformations and analyses • Execute and validate end-to-end analysis workflows across clinical trial datasets • Verify consistency across raw data, SDTM, ADaM, and TLF layers • Review data lineage and traceability across the full analysis pipeline • Design biostatistics and clinical-data analysis assignments • Produce task instructions, expected deliverables, and authoritative reference outputs • Define objective criteria for accuracy, traceability, statistical validity, and completeness

🎯 Requirements

• 5+ years of professional biostatistics experience; 10–25 years preferred • Hands-on experience across SDTM, ADaM, and TLF workflows • Demonstrated experience supporting pre-market Phase I–III clinical trials • 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 • Minimum availability of approximately 20–25 hours per week • Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, or other third party • H1-B and STEM OPT support is unavailable for this engagement

🏖️ Benefits

• Part-time independent contractor engagement • Fully remote • Flexible scheduling based on project requirements • Projects may be extended, shortened, or concluded based on project needs and performance