Director of Biostatistics - Remote

Overview

The Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

In Short

• Leads statistical and statistical programming team at the product level
• Provides statistical input to strategic planning and study design
• Guides study team on all aspects of statistical activities
• Collaborates with various departments to meet project deliverables
• Oversees CRO biostatisticians and statistical programmers
• Contributes to documents submitted to Health Authorities
• Coordinates statistical analyses for safety updates

Requirements

• PhD in statistics or biostatistics with 8+ years of experience
• NDA submission experience
• Strong knowledge of statistical methodologies
• Excellent programming skills in SAS and/or R
• Strong analytical and problem-solving skills
• Excellent communication skills
• Able to work collaboratively in a fast-paced environment

Benefits

• Patient Days to hear from individuals living with conditions
• A culture inspired by values of patient-first and transparency
• Access to learning and development resources
• Market-competitive compensation and benefits package
• Flexible PTO
• Rapid career advancement for strong performers
• Commitment to Diversity, Equity & Inclusion