MAIN RESPONSIBILITIES

• Provide comprehensive statistical support for IVD clinical and pre-clinical studies, covering study design, sample size calculation, randomization strategy, and statistical analysis plans (SAPs).
• Perform data cleaning, statistical analysis, and interpretation across diverse datasets, ensuring data integrity and consistency for robust analytical outcomes.
• Demonstrates strong expertise in statistical concepts and methodologies; identifies and corrects flaws in scientific reasoning and statistical interpretation.
• Ensure accurate classification, internal consistency, and quality control of statistical tables and data listings; verify the accuracy of report text and maintain consistency between summary tables in the main report and corresponding statistical outputs.
• Provide statistical training and technical support to cross-functional team members from clinical, medical, regulatory, and other non-statistical backgrounds.
• Participate in project meetings and provide expert statistical insights to support study planning and decision-making.

QUALIFICATIONS

• Statistics or related fields, Master degree 
• At least 1 year of experience in the IVD, pharmaceutical, or CRO industry.

• Proficient in SAS, R software, with expertise in statistical design and analysis for research projects. Capable of building and maintaining database libraries, managing clinical trial data, and experienced in the operation, maintenance, and oversight of clinical databases.