Senior Statistical Programmer
- Location: Bloemfontein
- Employment Type: Full-Time, Permanent
- Work Arrangement: On-site
- Industry: Clinical Research, Biostatistics, Data Science, Pharmaceutical Research
Job Description
The Senior Statistical Programmer is responsible for developing, validating, and maintaining statistical programming solutions used in clinical research studies. The role involves creating CDISC-compliant datasets, generating statistical reports, ensuring regulatory compliance, and contributing to innovative automation projects that improve clinical trial reporting processes.
The successful candidate will work closely with biostatisticians, data managers, clinical teams, and software developers to support the analysis and reporting of clinical trial data.
Key Responsibilities
Clinical Study Review and Analysis
- Review and interpret study documentation, including:
- Study Protocols
- Case Report Forms (CRFs)
- Statistical Analysis Plans (SAPs)
- Ensure programming deliverables align with study objectives and regulatory requirements.
Statistical Programming
- Develop and validate statistical programs using:
- SAS
- R Programming
- Generate CDISC-compliant:
- SDTM (Study Data Tabulation Model) datasets
- ADaM (Analysis Data Model) datasets
- Create efficient, reusable, and well-documented code.
Data Validation and Quality Control
- Perform quality control and validation of:
- Statistical programs
- Clinical datasets
- Statistical outputs
- Verify data integrity and compliance with study specifications.
- Identify, document, and resolve programming and data issues.
CDISC Standards Management
- Develop and review:
- SDTM mapping specifications
- ADaM specifications
- Ensure all datasets comply with CDISC standards and regulatory expectations.
Statistical Reporting
- Produce and review:
- Tables
- Figures
- Listings (TFLs)
- Ensure outputs comply with Statistical Analysis Plans and reporting standards.
Regulatory Submission Support
- Generate and review submission documents, including:
- define.xml
- Annotated CRFs
- Reviewer Guides
- Support preparation of regulatory submission packages.
Automation and Innovation
- Develop utility macros and automation tools.
- Participate in software development projects aimed at automating clinical reporting processes.
- Contribute to initiatives using:
- CDISC 360i
- Analysis Results Standard (ARS)
- USDM
- Analysis Concepts
- Support end-to-end automation from Statistical Analysis Plans to Clinical Study Reports.
Project and Team Collaboration
- Work effectively within multidisciplinary project teams.
- Manage multiple studies and programming assignments simultaneously.
- Ensure deliverables are completed within timelines and budget requirements.
- Communicate project progress and risks to stakeholders.
Compliance and Governance
- Adhere to company policies, SOPs, and regulatory guidelines.
- Maintain high standards of data quality and documentation.
Minimum Requirements
Education
Either:
- Master’s Degree (or equivalent qualification) with at least 3 years of SAS/R programming experience
OR
- Bachelor’s Degree with at least 5 years of SAS/R programming experience
Technical Requirements
- Strong proficiency in:
- SAS Programming
- R Programming
- Thorough understanding of:
- CDISC Standards
- SDTM
- ADaM
- Experience creating TFLs and clinical trial datasets.
Preferred Qualifications and Experience
The following are advantageous:
- Experience with CDISC 360i.
- Knowledge of Analysis Results Standard (ARS).
- Software development experience.
- Experience with automation projects, including:
- SAS Macro Development
- Process Automation
- Robotic Process Automation (RPA)
- Experience using AI tools responsibly to improve productivity and efficiency.
Key Competencies
Technical Expertise
- Advanced statistical programming skills.
- Clinical trial data management knowledge.
- Regulatory submission experience.
- Strong understanding of data standards.
Analytical Skills
- Excellent problem-solving abilities.
- Strong attention to detail.
- Ability to identify and resolve data quality issues.
Project Management
- Ability to manage multiple projects simultaneously.
- Strong organisational and prioritisation skills.
- Ability to work independently with minimal supervision.
Communication and Leadership
- Strong interpersonal and communication skills.
- Ability to collaborate across multidisciplinary teams.
- Leadership capabilities and mentoring potential.