Principal Statistical Programmer- IQVIA x1
Position Information
- Job Title: Principal Statistical Programmer
- Company: IQVIA
- Reference Number: R1551699
- Location: Bloemfontein
- Work Arrangement: Fully Remote / Home-Based
- Travel Requirement: No travel required
- Employment Type: Full-time
- Business Unit: Clinical FSP (Sponsor-Dedicated)
Job Purpose
The Principal Statistical Programmer is responsible for designing, developing, reviewing, and validating clinical trial datasets and statistical outputs used for regulatory submissions. The role ensures that clinical data are submission-ready and comply with industry standards such as CDISC SDTM and ADaM.
This senior-level position also leads programming activities across multiple studies, supports regulatory submissions, and develops tools to improve programming efficiency.
Key Responsibilities
1. Statistical Programming
- Design and develop SAS programs for clinical data analysis.
- Create and validate:
- ADaM datasets
- Tables
- Figures
- Listings (TFLs)
- Submission packages
- Develop and maintain SAS macros to automate processes.
- Use R programming for statistical analyses where applicable.
2. Clinical Data Standards and Compliance
- Ensure compliance with CDISC standards, including:
- CDASH
- SDTM
- ADaM
- Ensure submission readiness for regulatory authorities.
- Prepare define.xml documentation and related metadata.
3. Data Analysis and Reporting
- Conduct pooled and exploratory analyses across multiple studies.
- Support:
- Integrated Summary of Safety (ISS)
- Integrated Summary of Efficacy (ISE)
- Generate outputs for:
- Regulatory submissions
- Publications
- Presentations
- Clinical trial reporting
4. Cross-functional Collaboration
- Collaborate with:
- Statisticians
- Clinical programmers
- Clinical Research & Development teams
- Study teams
- Provide expertise on data structures and specifications.
5. Leadership and Oversight
- Lead programming activities for complex projects.
- Oversee timelines and deliverables.
- Develop global tools to improve efficiency and capacity.
- Mentor and guide team members when required.
Minimum Qualifications
Education
- Bachelor of Science (BSc) in:
- Computer Science
- Mathematics
- Statistics
- Related field
Experience
- Minimum 7 years’ experience in:
- Clinical Programming
- Statistical Programming
- CRO or Pharmaceutical industry environments
Technical Requirements
Programming Skills
- Advanced SAS programming
- SAS Macros development
- R Programming (hands-on experience)
Clinical Data Standards
Strong knowledge of:
- CDASH
- SDTM
- ADaM
- define.xml
Regulatory Knowledge
- Clinical trial regulations
- Regulatory submissions
- Submission-ready datasets
Required Skills and Competencies
Technical Competencies
- Statistical analysis
- Clinical data management
- Data validation and quality control
- Programming and automation
- Problem-solving and analytical skills
Professional Competencies
- Project management
- Time management
- Leadership skills
- Communication skills
- Collaboration across international teams
- Ability to work independently
Working Environment
This is a fully remote home-based role with no travel requirements. The role involves working with global, multicultural clinical research teams across different regions and time zones.