Senior Statistical ProgrammerIndia, Remote Job ID 77002BR Category Statistical Programming
About this Role
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory 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 and/or lead process/quality improvement initiatives.
- Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
- Represent Parexel at sponsor marketing and technical meetings.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
- Excellent analytical skills.
- Proficiency in SAS.
- Extensive 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.
- Strong project management skills.
- Strong organizational skills, ability to manage competing priorities, and flexibility to change.
- Attention to detail.
- Ability to successfully lead a global team.
- Work effectively in a quality-focused environment.
- Effective time management in order to meet daily metrics or team objectives.
- Show commitment to and perform consistently high quality work.
- Business/operational skills that include customer focus, commitment to quality management, and problem solving.
- Demonstrate commitment to refine quality processes.• Good presentation skills.• Good business awareness/business development skills (including financial awareness).