Associate Director, Biostatistics

Overview

• Lead biostatistical efforts for clinical trials, ensuring statistical integrity and compliance with regulatory guidelines.
• Collaborate with cross-functional teams to design studies and analyze data effectively.
• Provide expertise in statistical methodologies to enhance study results and efficiency.
• Develop and review statistical analysis plans, protocols, and study documentation.
• Contribute to regulatory submissions and scientific publications as a statistical expert.
• Work remotely, managing multiple tasks and priorities within tight timelines.
• Engage in innovative research to advance statistical standards and methodologies.

Key Responsibilities & Duties

• Design clinical trials, determining sample sizes and statistical approaches.
• Author and review statistical sections in protocols, SAPs, and DMC charters.
• Develop and validate randomization files and TFL specifications.
• Ensure compliance with ICH guidelines and regulatory requirements.
• Collaborate with biometrics and cross-functional teams to meet project deliverables.
• Conduct advanced statistical analyses and propose novel methodologies.
• Review CRFs and other study-related documentation for accuracy.
• Participate actively in study-related meetings and discussions.

Job Requirements

• PhD in Statistics/Biostatistics with 5+ years or MS with 8+ years of experience.
• Proven expertise in clinical trials and regulatory submissions (NDA/BLA/MAA).
• Proficiency in SAS and R; knowledge of CDISC standards preferred.
• Solid understanding of statistical principles and regulatory guidelines.
• Experience as a study lead statistician in cross-functional settings.
• Strong organizational, problem-solving, and prioritization skills.
• Ability to manage multiple tasks and meet tight deadlines.
• Familiarity with FDA/EMA regulatory requirements and statistical methodologies.