Senior Statistician- Metronomia Clinical Research x1
- Position: Senior Statistician
- Company: Metronomia Clinical Research
- Location: Bloemfontein, Free State, South Africa
- Employment Type: Full-Time
- Industry: Clinical Research / Biostatistics / Pharmaceutical Research
Purpose of the Role
The Senior Statistician is responsible for leading and delivering biostatistical services for clinical trials and pharmaceutical research projects. The role involves designing statistical analysis plans, managing statistical deliverables, advising clients on study design, ensuring regulatory compliance, and serving as the primary statistical contact for biotechnology and pharmaceutical clients.
Key Responsibilities
Statistical Analysis and Clinical Trial Support
- Develop Statistical Analysis Plans (SAPs).
- Define estimands, statistical models, and hypothesis tests.
- Design mock tables, listings, and figures (TFLs).
- Conduct statistical analyses for clinical studies.
- Support protocol development and study design activities.
Project Leadership
- Coordinate teams of statisticians and statistical programmers.
- Ensure quality and timely delivery of:
- SDTM datasets
- ADaM datasets
- Tables, Listings and Figures (TFLs)
- Monitor project timelines and deliverables.
Quality Control
- Review datasets and statistical outputs.
- Perform independent programming validation.
- Reprogram complex datasets and analyses using SAS.
- Ensure data integrity and regulatory compliance.
Client Management
- Serve as the primary statistical contact for clients.
- Respond to statistics-related enquiries.
- Participate in client meetings and consultations.
- Present statistical solutions and recommendations.
Data Review and Decision-Making
- Chair Data Review Meetings (DRMs).
- Lead discussions regarding data quality and analysis.
- Document decisions and outcomes.
- Ensure appropriate implementation of agreed actions.
Clinical Trial Reporting
- Author or review statistical sections of:
- Clinical Trial Reports (CTRs)
- Regulatory submissions
- Study reports
- Review presentation and interpretation of study results.
Independent Data Monitoring Committee (IDMC) Support
- Act as Independent Statistician where required.
- Prepare IDMC reports.
- Organise and facilitate IDMC meetings.
- Support safety and efficacy reviews.
Budget and Financial Management
- Manage project budgets.
- Track project performance.
- Prepare financial reports.
- Initiate and manage change orders when necessary.
Business Development
- Participate in Bid Defence Meetings.
- Present company biostatistical capabilities.
- Support proposal development and client acquisition efforts.
Regulatory and Audit Support
- Represent the biostatistics department during:
- Regulatory inspections
- Customer audits
- Compliance reviews
Minimum Requirements
Qualifications
- Degree in:
- Statistics
- Mathematics
- Mathematical Biometrics
- Or a related quantitative discipline
Experience
- Minimum of three years’ experience as a Statistician within:
- Contract Research Organisations (CROs)
- Pharmaceutical companies
- Clinical research environments
- Previous project leadership responsibility.
Technical Knowledge
- Strong knowledge of:
- Clinical trial statistics
- Regulatory guidelines
- CDISC standards
- Statistical programming and validation
- SAS programming
Soft Skills
- Excellent communication skills.
- Strong client relationship management abilities.
- Leadership and project coordination skills.
- Analytical and problem-solving capabilities.
Benefits
Work Environment
- Hybrid working arrangements.
- Flexible and family-friendly culture.
- Flat organisational structure.
- Collaborative team environment.
Career Development
- Comprehensive onboarding.
- Internal and external training opportunities.
- Professional growth and development support.
Compensation
- Competitive remuneration package.
- Health and wellness benefits.
- Additional employee benefits package.