Reporting Line
Operational direct reporting to Affiliate Manager or Supervisor; administrative accountability to RBS Supervisor.
Primary Responsibilities
Responsible for providing statistical support in the clinical research, including monitoring and querying data from the database, managing study data, executing the statistical analysis, providing statistical reports, validating statistical analysis. Will also involve in reviewing research protocol drafts and the report draft, and in assisting the statistics manager in the design of appropriate statistical analysis plans and keep track of due dates. Will be responsible to answer sponsors' questions when the statistics manager is not available.
Specific Responsibilities
- At all times, complies with SGS Code of Integrity and Professional Conduct.
- Develop and program comprehensive Statistical Analysis Plans (SAPs) in alignment with study objectives and regulatory requirements.
- Perform statistical programming, including the generation and validation of analyses and data listings to ensure accuracy and integrity.
- Present statistical results clearly and professionally, and contribute to the preparation of study reports.
- Conduct rigorous statistical quality control checks to maintain high standards of data reliability and compliance.
- Enhance and maintain SAS macros to support standardized and efficient analytical processes.
- Ensure full knowledge of, and adherence to, SGS procedures, guidelines, and quality standards.
- Ensures work area in GBS is kept clean and presentable at all times.
- Remains familiar with SGS quality assurance procedures.
- Complies to all SGS QHSE and HR policies and procedures