Biostatistician – Clinical Trials

Responsibilities

• Design and develop statistical analysis plans (SAPs) for clinical trials across all phases.
• Perform statistical analyses using SAS and R, and generate tables, listings, and figures (TLFs).
• Collaborate with clinical teams on study design, sample size estimation, and endpoint selection.
• Review clinical study reports (CSRs) and contribute to regulatory submission documents.
• Provide statistical expertise for Data Safety Monitoring Board (DSMB) meetings.

Requirements

• Master's or PhD in Biostatistics, Statistics, or Mathematics.
• 3-6 years of experience in pharmaceutical biostatistics or CRO environment.
• Proficiency in SAS (Base, STAT, Graph) and R programming.
• Knowledge of CDISC standards (SDTM, ADaM) and ICH E9 guidelines.
• Strong analytical thinking and ability to communicate complex results clearly.