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.

- Robust communication, interpersonal and organization skills.

- Self-motivated, proactive and detail oriented.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Data Standards SME (Bengaluru)
🏢 Emmess Services
📍 Bengaluru