Description

You will act as the lead biostatistician for drug development programs, managing statistical aspects from study design through regulatory submission. You'll collaborate with cross-functional teams, design protocols, perform analyses, and interact with regulatory agencies, all while working in a hybrid environment across NJ/PA/DE.

Requirements

• Experience as a lead statistician for clinical studies
• Ability to work independently and establish high-trust client relationships
• Strong knowledge of drug development lifecycle and regulatory interactions
• Experience with sample size calculations and protocol design
• Familiarity with statistical methodologies and SAS or similar software

Responsibilities

• Provide statistical input on design, analysis, and interpretation of Phase I-IV clinical trials, ISS, and ISE
• Draft or review statistical analysis plans (SAP) and mock tables, listings, and figures (TLF)
• Perform review of TLFs for accuracy across outputs for CSR, IDMC, or publications
• Manage project timelines and interact with external vendors
• Prepare presentations and interpret results for data review meetings