Statistical Programmer II – R Programming
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Job Description
Statistical Programmer II responsible for programming and reporting clinical trial data using R. Leading initiatives in a flexible, home-based role, contributing to Parexel's mission.
Responsibilities:
- Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
- Check own work in an ongoing way 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 and QC low-medium complexity derived datasets, tables, figures, and data listings.
- Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.
- Maintain and expand local and international regulatory knowledge within the clinical industry.
- Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
- Provide relevant training and mentorship to staff and project teams as appropriate.
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator compliance.
- Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
- Proactively participate in process/quality improvement initiatives.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
Requirements:
- Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences
- Excellent analytical skills
- Intermediate level of R programming language
- Knowledge and understanding of the programming and reporting process
- Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11
- Ability to learn new systems and function in an evolving technical environment
- Ability to manage competing priorities and flexibility to change
- Ability to successfully work as part of a global team
- Effective time management in order to meet daily metrics or team objectives
- Business/operational skills that include customer focus, commitment to quality management, and problem solving
- Strong understanding of CDISC standards
- Knowledge of statistical terminology, clinical tests, and protocol designs
- Excellent attention to detail with a focus on quality
- Strong written and verbal English communication skills.
Benefits:
- participation in Parexel’s annual performance-based bonus plan
- annual salary review
- total rewards incentives
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