Statistical Analyst
CurrentLead biostatistical programming activities for multiple clinical trials resulting in successful submissions to FDA, EMA, and NMPA, including handling time-sensitive regulatory agency requests. Generate detailed analysis plan documents such as ADaM and TFL specifications and review study outputs for template conformance. Contribute to SAP development, manage biostat deliverable timelines, and coordinate ADaM and TFL generation and validation. Collaborate with cross-functional international teams to contribute to overall study management and provide regulatory submission support. Generate analysis and validation programs for ADaM and TFLs, including implementation of high-level analysis methods such as multiple imputation, MMRM, robust regression, survival analysis, and others. Create SAS macros for team use to improve programming efficiency. Play a key role in SOP improvement initiatives, enhance programming templates, and lead department trainings such as BIMO conformance. Assist and mentor junior programmers.
