Tech Stack

Description

You will lead the statistical efforts of a clinical program, contributing to clinical development plans, regulatory submissions, and data strategy. You'll oversee outsourced statistical functions and ensure compliance with global standards.

Requirements

• Advanced degree in Statistics or related field with 6+ years clinical trial experience
• Deep knowledge of FDA, EMA, ICH guidelines
• Expertise in SAS; R or Python advantageous
• Experience with trial design software (EAST, nQuery)
• Strong communication and cross-functional collaboration skills

Responsibilities

• Lead statistical efforts for a clinical program
• Contribute to clinical development plans and regulatory submissions
• Author statistical methods sections and develop analysis plans
• Oversee and quality control results from CROs
• Support scientific publications and presentations