Overview
In this role you drive statistical programming for clinical trials, acting as a technical SME and, when needed, leading programming on projects. You collaborate with sponsors and cross-functional teams to ensure quality, timelines, and regulatory compliance. You will support end-to-end data processing and submission-ready outputs while mentoring staff and advancing process improvements. The position blends hands-on SAS work with leadership duties in a globally distributed team, within Parexel’s mission to improve patient outcomes.
Pay / Benefits
- work life balance
- flexible working hours
- professional growth and development opportunities
- collaborative and inclusive environment
Responsibilities
- Fill Statistical Programming Lead role on projects
- Negotiate and ensure adherence to programming timelines
- Coordinate and lead a statistical programming team to meet study timelines and budget
- Monitor resourcing and budgets; manage scope changes
- Coordinate start-up activities and documentation (global programs, tracking sheets)
- Review statistical analysis plans and database specifications
- Interact with sponsors and internal stakeholders on programming issues
- Assist teams in resolving daily programming problems
- Deliver high-quality, value-driven programming services
- Perform QC on derived datasets, tables, figures, and listings (SDTM, ADaM)
- Produce/dQC dataset specifications and submission documentation
- Ensure QC per SOPs, ICH-GCP, and regulatory requirements
- Maintain regulatory knowledge and training in SAS and related processes
- Provide training and mentorship to staff and project teams
- Maintain study documentation for traceability and compliance
- Support audits and inspections as required
- Lead process/quality improvement initiatives
- Provide consultancy on statistical programming tasks to sponsors
- Represent Parexel in sponsor meetings
- Understand regulatory standards (CDISC, 21 CFR Part 11)
Key requirements
- University degree
- Strong English communication
- Proficiency in SAS
- Excellent analytical skills
- Ability to lead a global team
- Extensive knowledge of programming and reporting processes
- Knowledge of SOPs/Guidelines, ICH-GCP, and 21 CFR Part 11
- Ability to learn new systems in evolving technical environments
- Strong project management skills
- Strong organizational skills; ability to manage priorities
- Attention to detail
- Effective time management for metrics/targets
- Business and customer-focused mindset
- Good presentation skills
- Business development awareness
- strong communication
- leadership
- problem solving
- SAS proficiency
- CDISC knowledge
- ICH-GCP knowledge
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