Data Standards SME

Emmes

About The Position

Be Part of One Team, One Purpose. At Emmes Group, we’re shaping the future of clinical research— where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units— Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people —people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability. The Data Standards SME provides data standards support for clinical projects. Key responsibilities include developing clinical data standards, including CDISC SDTM for CRF and non-CRF data, controlled terminology, and mappings for non-CRF standard data, as well as database builds involving CDASH. Additionally, the role also includes collaborating with clinical research, biostatistics, and data management teams to ensure study design aligns with CDISC requirements.

Requirements

Bachelor's Degree Required
Master's 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.

Responsibilities

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