Data Management Consultant – Statistical Computing EnvironmentEliassen Group • New York, New York, United States
Data Management Consultant – Statistical Computing Environment
Eliassen Group
- New York, New York, United States
- New York, New York, United States
À propos
Remote Our client is implementing a Statistical Computing Environment to support biometrics and clinical development. The consultant will embed Data Management standards, structures, and traceability into the platform and align processes across IT, Biostatistics, and Programming. The role focuses on defining data flows, metadata, and CDISC implementation while advising on validation, access, and inspection readiness. The engagement is part-time and fully remote. Rate: $100.00 to $90.00/hr. w2 Responsibilities
Partner with IT and Biostatistics stakeholders to integrate Data Management requirements into the SCE design and implementation. Define and document data standards, structures, metadata, and lineage requirements to ensure traceability and regulatory readiness. Support design of end-to-end data flows across clinical data sources, downstream analytics, and reporting within the SCE. Advise on process alignment between Data Management, Biostatistics, and Programming to support efficient study execution. Ensure Data Management considerations are incorporated into validation, access controls, audit trails, and inspection readiness activities. Provide practical guidance on CDISC standards (SDTM/ADaM) and how they are operationalized within the SCE. Identify risks, gaps, or inefficiencies related to data handling and recommend pragmatic solutions. Support cross-functional communication and change management as teams transition to the new environment. Experience Requirements
8+ years of experience in Clinical Data Management within biotech, pharma, or CRO environments. Hands‑on experience working alongside Biostatistics and Statistical Programming teams. Strong understanding of clinical data standards, including CDISC SDTM and ADaM, and regulated data environments. Knowledge of data flow architecture, metadata management, and data traceability supporting clinical analysis and submissions. Ability to operate independently in a consultative capacity and deliver results in a fast‑paced, small biotech environment.
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Compétences linguistiques
- English
Avis aux utilisateurs
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