Data Standards SME

Job Summary

Provides data standards support for multiple complex clinical research study projects or study teams.

Responsibilities

• Provides guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotation CRF, define.xml/pdf, Reviewer s Guide, XPT .
• Participates in development of all clinical data standard such as CDISC Study Data Tabulation Model (SDTM) for both CRF (Case Report Form) and non-CRF data, controlled terminology, mappings for non-CRF standard data (e.g., lab or ECG), data base builds in CDASH format and other pertinent industry standards.
• Actively provides insights and recommendations to Data Management regarding areas such as CRF design, programmed edit checks, and data transfer specifications.
• Provides inputs to the Statistical Programming teams regarding SDTM mapping specifications and the SDTM annotated CRF.
• Develops programming documentation and annotations including specifications while adhering to relevant Standard Operating Procedures.
• Actively collaborates with cross-functional teams, such as clinical research, biostatistics, and data management, to align the study design with CDISC requirements.
• Develops expertise in current CDISC standards to ensure the adoption and implementation of sound CDISC requirements.
• Actively participates and presents internally and externally at industry forums, conferences, or working groups.
• Provides project updates to appropriate project management or department management staff.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelors Degree Required
• Masters Degree Preferred
• PhD Preferred
• 4-6 years of experience as a Data Standards expert in a pharmaceutical or CRO environment (6+ years with a bachelor s degree; 4+ years with a master s or doctoral degree).
• 1 year Hands-on experience developing clinical data standards, including CDISC SDTM for CRF and non-CRF data, controlled terminology, and mappings for non-CRF standard data (e.g., lab, ECG).
• 1 year Experience supporting database builds in CDASH format and other clinical data standards.
• 1 year Proven experience collaborating with cross-functional teams, including clinical research, biostatistics, and data management, to ensure study design aligns with CDISC requirements.
• 1 year Knowledge and practical experience providing guidance on SDTM annotations, define.xml/pdf, Reviewer s Guides, and XPT files for submission-ready datasets.
• 1 year Experience contributing to CRF design, programmed edit checks, data transfer specifications, and SDTM mapping specifications for statistical programming teams.
• 1 year Participation in internal and external forums, conferences, or working groups to share expertise and stay current on evolving CDISC standards.
• 1 year Strong record of preparing programming documentation, specifications, and annotations in compliance with SOPs and regulatory guidance.
• Understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, and ICH guidance and recommendations) in Clinical Research.
• Good analytical skills with the ability to process scientific and medical data.
• Ability to manage multiple tasks and priorities independently.
• Ability to work independently as well as in a team environment.
• Strong skills in prioritization, problem-solving, organization, decision-making, and time management.
• Understand and articulate technical concepts through written and oral communication.
• Strong communication, interpersonal and organization skills.
• Self-motivated, proactive and detail oriented.

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