Tech Stack

Description

You will shape the design, analysis, and interpretation of clinical trial data for precision neuromedicine programs. Collaborating with multidisciplinary teams, you'll ensure statistical rigor and data integrity from protocol development to regulatory submissions.

Requirements

• PhD with 3+ or MS with 6+ years (Senior Manager); PhD with 6+ or MS with 9+ years (Associate Director) in biostatistics
• CNS therapeutic area experience preferred
• Skilled in SAS, R, or Python for data analysis, graphing, and simulation
• Comprehensive knowledge of clinical trial design, advanced statistical methods, and regulatory guidelines
• Ability to communicate complex statistical concepts clearly

Responsibilities

• Oversee protocol development including study design, endpoint selection, sample size calculation, and statistical methods
• Support statistical programming to deliver SDTM and ADaM datasets, TLFs
• Ensure compliance with CDISC and regulatory guidelines (ICH, FDA, EMA)
• Provide statistical input and interpretation for clinical study reports and regulatory submissions
• Perform and validate statistical analyses using SAS and/or R