Associate Director- Biostatistics

Tech Observer; United States; Remote; USD 80,000 - 130,000; Full time

Job summary

A leading organization in clinical research seeks an expert in statistical analysis to support various therapeutic projects. The candidate will provide guidance for dossier submissions, manage multiple projects, and design clinical studies while ensuring adherence to statistical methodologies. This role is pivotal in ensuring the quality and integrity of clinical research outcomes.

Qualifications

• Experience in managing multiple clinical research projects.
• Proficiency in statistical analysis and methodology.
• Ability to write and review clinical study protocols.

Responsibilities

• Provide guidance to CRO for statistical analysis.
• Support dossier submissions and respond to inquiries.
• Design clinical studies and determine sample sizes.

Skills

Statistical methodologies

Clinical study design

Project management

Job description

Expertise in Early Phases: Provides guidance to the Clinical Research Organization (CRO) for appropriate conduct of statistical analysis. Supports dossier submissions and responds to statistical questions related to the file. Writes and reviews the statistical section of protocols.

Required Candidate Profile: Manages multiple projects across different therapeutic areas. Applies appropriate statistical methodologies and endpoint definitions. Designs clinical studies and determines associated sample sizes.