Log In
Sign Up
Summary:
- Parexel’s mission is to improve global health through clinical trials, regulatory, consulting, and market access services.
- As a Statistical Programmer II, the role focuses on technical expertise for clinical trial conduct, particularly in data analysis and reporting.
- The position includes potential leadership responsibilities on smaller, non-complex projects.
- The role offers an opportunity to contribute to the development of therapies that will benefit patients worldwide.
Responsibilities:
- Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
- Deliver high-quality service and check work continuously to ensure first-time quality.
- Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity.
- Assist in the production and QC of derived dataset specifications and submission documentation.
- Maintain and expand local and international regulatory knowledge within the clinical industry.
- Provide training and mentorship to staff and project teams.
- Maintain supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
- Ensure compliance with SOPs/Guidelines, ICH-GCP, and other applicable regulations and participate in audits and inspections.
- Proactively participate in process/quality improvement initiatives.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11).
Requirements:
- Minimum of 3 years of experience in clinical research with sound SAS programming skills.
- Experience with CDISC standards (SDTM, ADaM).
- Educated to degree level in a relevant discipline or equivalent work experience.
- Proficiency in SAS and a good understanding of the programming and reporting process.
- Knowledge of SOPs/Guidelines, ICH-GCP, and applicable regulations such as 21 CFR Part 11.
- Competency in written and oral English, with good communication skills.
- Ability to manage competing priorities and adapt to change.
- Attention to detail and effective time management.
- Ability to work as part of a global team and in a quality-focused environment.
Benefits:
- Highly qualified and dynamic team in a multinational working environment.
- Smooth induction and training program.
- Competitive financial packages, training, and development.
- Work-life balance and flexible work arrangements, including fully home-based options.
- Welcoming work environment for those living near Bloemfontein office.
