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Cdisc Sdtm Jobs (NOW HIRING)

ImmunityBio, Inc.

Principal Statistical Programmer

A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading CDISC expertise and programming leadership. They contribute to process improvements and initiatives ...

HCL America Inc.

Clinical SAS SDTM

North Wales, PA

Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines. Skill Requirements: * Extensive programming experience in a clinical trial environment (CRO/Pharma). * Expertise in SAS/BASE ...

Navitas Life Sciences

Senior Statistical Programmer

Working knowledge of CDISC, SDTM and ADaM * Expert knowledge of SAS-based statistical programming * Proficiency in SAS programming on multiple platforms and operating systems, e.g. Windows, UNIX, etc ...

Immunome, Inc.

SeniorEDC Programmer

Bothell, WA

Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...

Prometrika LLC

Principal Biostatistician

Cambridge, MA · On-site

$178K - $216K/yr

Perform mapping from raw datasets to CDISC SDTM datasets * Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission * Develop SAS programs to ...

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How much do cdisc sdtm jobs pay per hour?

As of Jun 14, 2026, the average hourly pay for cdisc sdtm in the United States is $54.04, according to ZipRecruiter salary data. Most workers in this role earn between $41.59 and $68.03 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Cdisc Sdtm position, and why are they important?

To thrive as a CDISC SDTM specialist, you need a deep understanding of clinical data management, strong knowledge of CDISC standards (particularly SDTM), and experience with statistical programming languages such as SAS. Familiarity with industry tools like Pinnacle 21, Medidata Rave, and relevant CDISC certifications is highly valued. Attention to detail, analytical thinking, and effective communication skills help distinguish top performers in this role. These capabilities are crucial for ensuring the accurate, compliant, and efficient transformation of clinical trial data into standardized formats for regulatory submission.

What is a CDISC SDTM job?

A CDISC SDTM job involves working with clinical trial data to ensure it complies with the Study Data Tabulation Model (SDTM) standard set by the Clinical Data Interchange Standards Consortium (CDISC). Professionals in this role transform raw clinical data into standardized SDTM domains for regulatory submissions to agencies like the FDA. Responsibilities typically include data mapping, programming (using SAS), validation, and documentation. This role is crucial for ensuring data integrity, consistency, and compliance in clinical research.

What does a typical day look like for a CDISC SDTM specialist?

A typical day as a CDISC SDTM specialist involves mapping raw clinical trial data to SDTM standards, collaborating closely with data managers, biostatisticians, and clinical programmers to resolve data issues, and validating data sets for consistency and compliance. You may also participate in meetings to discuss project progress, handle quality control checks using specialized software, and prepare documentation for regulatory submissions. The role often requires balancing independent programming work with teamwork across various functions in a dynamic, deadline-driven environment. This diverse set of tasks provides an engaging workday for those who enjoy both problem-solving and cross-functional collaboration.

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Cdisc Sdtm jobs near you
Infographic showing various Cdisc Sdtm job openings in the United States as of June 2026, with employment types broken down into 75% Full Time, and 25% Contract. Highlights an 58% In-person, 4% Hybrid, and 38% Remote job distribution, with an average salary of $112,399 per year, or $54 per hour.
Senior Clinical Data Management SME

Senior Clinical Data Management SME

VLS Systems Inc

Alameda, CA

Other

Posted 13 hours ago

Job description

We are seeking a Senior Clinical Data Management SME to provide clinical data leadership across active studies. This role will own clinical data standards, study-level data management planning, data quality planning, SDTM/ADaM mapping oversight, CRO/vendor data onboarding, and translation of clinical study requirements into data pipeline specifications.


The role requires deep experience in clinical data management, CDISC standards, SDTM/ADaM, eCRF design, study protocols, data quality, vendor governance, and clinical data delivery.


Key Responsibilities

  • Serve as the primary Clinical Data Management SME across active clinical studies.

  • Own and maintain CDISC standards, Clinical Data Management Plans, and Data Quality Plans.

  • Own SDTM/ADaM mapping authority across studies and validate domain conformance.

  • Review and approve SDTM/ADaM mappings, data quality rules, and study artifacts before release to production.

  • Govern CRO and vendor data onboarding, including data transfer plans, SLAs, acceptance criteria, in-stream data flows, and exception handling.

  • Translate study protocols, eCRFs, and reporting/analysis plans into pipeline requirements for data engineering teams.

  • Partner with Clinical Operations, Biostatistics, Data Management, CROs, data engineers, and data managers.

  • Ensure study data is complete, accurate, traceable, standardized, and ready for downstream analysis.

  • Provide SME guidance to offshore engineers and data managers on clinical data standards, mappings, and study-specific requirements.

  • Support issue resolution related to clinical data quality, mapping gaps, transformation logic, and vendor data defects.


Required Qualifications

  • 10+ years of experience in Clinical Data Management within pharma, biotech, or CRO environments.

  • Strong working knowledge of CDISC, SDTM, and ADaM standards.

  • Experience with:


  • Clinical Data Management Plans

  • Data Quality Plans

  • Data Transfer Plans

  • eCRF specifications

  • SDTM/ADaM mapping specifications

  • Edit checks and validation rules

  • Clinical data review and reconciliation


  • Ability to interpret study protocols, eCRFs, CRF annotations, reporting plans, and analysis plans.

  • Experience managing or coordinating with CROs and third-party data vendors.

  • Strong understanding of clinical trial data lifecycle from data collection through analysis and submission readiness.

  • Ability to convert clinical requirements into clear technical specifications.

  • Strong communication and stakeholder management skills.


Preferred Qualifications

  • Experience with regulatory submission data packages.

  • Experience with EDC systems, clinical data repositories, clinical data hubs, or clinical data platforms.

  • Familiarity with metadata-driven pipelines, automation, or AI-assisted data mapping and rule generation.

  • Experience supporting oncology or specialty pharma studies.

  • Experience working with distributed onsite/offshore delivery teams.

  • Knowledge of data governance, lineage, auditability, and quality controls in clinical data environments.


Key Skills

Clinical Data Management, CDISC, SDTM, ADaM, eCRF, Study Protocols, Data Quality, Data Transfer Plans, CRO/Vendor Governance, Data Mapping, Clinical Data Standards, Edit Checks, Data Reconciliation, Regulatory Submission Readiness, Clinical Operations, Biostatistics, Data Engineering Collaboration.

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