SDTM Programmer and Mapper - Fulltime

  • Posted 5 hours ago | Updated 5 hours ago

Overview

Remote
Depends on Experience
Full Time
Accepts corp to corp applications
Able to Provide Sponsorship

Skills

SDTM Programmer and Mapper

Job Details

SDTM Programmer and Mapper - Fulltime- Remote

Position Summary

The SDTM Programmer and Mapper will be responsible for developing and validating CDISC-compliant SDTM datasets, ensuring data integrity and traceability throughout the clinical data flow. The role involves programming, mapping, and implementing standardized data structures using automation tools and integrating seamlessly with Apexon s AI/ML-based data transformation platforms.

The ideal candidate will bring hands-on experience in SDTM mapping, deep knowledge of CDISC/CDASH, and proficiency in SAS programming within a fast-paced, client-focused environment.

Education & Experience

  • Bachelor s or Master s degree in Life Sciences, Statistics, Computer Science, or related field.
  • 8-10 years of relevant experience in SDTM programming within a CRO, sponsor, or data standards environment.
  • Certification in SAS programming or CDISC SDTM preferred.

Key Responsibilities

  • Program, validate, and maintain SDTM datasets as per CDISC and client-specific standards.
  • Perform data mapping from raw clinical databases (EDC, lab, and safety systems) to SDTM domains.
  • Conduct SDTM compliance checks using Pinnacle 21 (Community/Enterprise) and address validation findings.
  • Create and maintain define.xml, annotated CRFs, and SDTM Reviewer s Guides for submission readiness.
  • Review CRFs, database specifications, and edit checks to ensure SDTM/CDASH alignment.
  • Collaborate with Data Management, Biostatistics, and AI platform teams to ensure consistency and quality in clinical data transformation.
  • Support regulatory submissions (FDA, EMA, PMDA) through clean, compliant, and validated deliverables.
  • Document programming activities following Google Cloud Platform and 21 CFR Part 11 standards.
  • Contribute to continuous improvement by sharing best practices, developing macros, and supporting automation initiatives across Apexon s data platforms.

Mandatory Technical Skills

  • Strong proficiency in SAS (Base, Macro, SQL) programming for clinical data handling.
  • In-depth understanding of CDISC standards: SDTM, CDASH, and Define.xml.
  • Hands-on experience with Pinnacle 21 Community/Enterprise for SDTM validation.
  • Experience in EDC data structures (Medidata Rave, Oracle Inform, or Veeva Vault EDC) and data integration.
  • Strong analytical and debugging skills to identify data inconsistencies and mapping issues.

Basic Knowledge (Preferred Exposure)

  • Familiarity with ADaM and TLF programming.
  • Understanding of submission packages (aCRF, cSDRG, define.xml).
  • Awareness of data visualization tools (Spotfire, Power BI) or metadata automation concepts.
  • Exposure to clinical data standards governance and metadata repositories.
  • Understanding of AI-based data mapping or automation frameworks used within clinical data transformation.

Soft Skills

  • Attention to detail and a strong sense of data accuracy and quality.
  • Effective communication skills for collaboration with global teams and clients.
  • Adaptability and flexibility in handling multiple projects and evolving priorities.
  • Proactive problem-solving attitude with ownership of deliverables.
  • Team player who contributes to a collaborative and innovation-driven environment.
  • Continuous learner open to training on new tools, technologies, and CDISC updates.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

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