DM/STDM Programmer- IQVIA x1
JOB DETAILS
- Position: DM/STDM Programmer
- Location: Bloemfontein, South Africa (Home-based / Remote), Also open to multiple countries in Europe
- Employment Type: Full-time, Remote / Home-based
- Company: IQVIA
- Industry: Clinical Research, Healthcare Data, Biostatistics
JOB DESCRIPTION
The DM/STDM Programmer is a technical data specialist role focused on managing and programming clinical trial data using SDTM standards.
This role involves:
- Programming and reviewing SDTM datasets
- Ensuring clinical data is accurate, standardized, and submission-ready
- Collaborating with sponsors, CROs, and internal teams
- Supporting regulatory submissions and compliance
It is a highly technical position combining SAS programming, data management, and clinical research knowledge.
KEY RESPONSIBILITIES
1. SDTM Programming & Review
- Program and review SDTM datasets
- Build and validate SDTM submission packages
- Ensure accuracy, quality, and completeness of data
2. Data Management & Oversight
- Plan and oversee data receipt for clinical trials
- Monitor data throughout the study lifecycle
- Ensure proper data standards and structure
3. Collaboration & Stakeholder Engagement
- Work with sponsors, CRO partners, and study teams
- Participate in project and technical meetings
- Support cross-functional teams (biometrics, regulatory, clinical teams)
4. Data Analysis & Reporting
- Program reports for data review and analysis
- Perform formal and ad-hoc data analyses
- Support decision-making with accurate data outputs
5. Quality Control & Compliance
- Review annotated CRFs and SDTM datasets
- Perform quality checks and validation
- Ensure compliance with:
- Good Clinical Practice (GCP)
- Data standards and regulatory requirements
6. Technical Documentation & Standards
- Write and review technical specifications
- Maintain consistency in SDTM standards and terminology
- Support creation of derived datasets (DE datasets)
7. Audit & Inspection Support
- Assist with audits and regulatory inspections
- Ensure readiness of clinical data for submission
REQUIREMENTS
Experience
- At least 5 years of SAS programming experience (preferred)
- Experience in:
- SDTM programming and deliveries
- Clinical data management
- Biometrics processes
Technical Skills
- Strong knowledge of:
- SAS programming
- SDTM (Study Data Tabulation Model)
- Data mapping and controlled terminology
- Experience with:
- Relational databases
- Clinical Data Management Systems (CDMS / EDC)
- Reporting tools
Industry Knowledge
- Clinical or pharmaceutical industry experience
- Understanding of:
- Good Clinical Practice (GCP)
- Clinical data standards and regulations
Core Capabilities
- Reviewing annotated CRFs
- Writing and reviewing technical specs
- Troubleshooting programming errors
- Log file analysis
KEY COMPETENCIES
Technical Competencies
- Advanced SAS programming
- Strong analytical and problem-solving skills
- Data quality and validation expertise
Professional Skills
- Strong written and verbal communication (English)
- Ability to work independently in a remote environment
- Collaboration with global teams
Personal Attributes
- Detail-oriented and quality-focused
- Organized and deadline-driven
- Adaptable and proactive
ABOUT THE ROLE
This is a specialist-level position ideal for experienced professionals in:
- Clinical data programming
- Biostatistics
- Pharmaceutical research
It plays a critical role in ensuring that clinical trial data is compliant, accurate, and ready for regulatory submission.
IMPORTANT NOTES
- Requires advanced technical expertise (not entry-level)
- Strong emphasis on data quality and regulatory compliance
- All application details must be accurate and truthful