Associate Director Of Biostatistics

Associate Director of Biostatistics Overview

• The Associate Director of Biostatistics plays a pivotal role in driving clinical development strategies for innovative drug candidates.
• Collaborate with cross-functional teams to design and implement clinical trials aligned with regulatory standards and scientific rigor.
• Contribute to statistical analysis plans, clinical trial protocols, and regulatory documentation to support drug development initiatives.
• Provide statistical guidance and expertise throughout the trial lifecycle, ensuring data integrity and compliance.
• Work with global teams across 19 countries, contributing to the development of groundbreaking pharmaceutical products.
• Leverage advanced statistical tools and methodologies to enhance trial design and data analysis processes.
• Engage with regulatory authorities, key opinion leaders, and stakeholders to represent the client effectively.
• Contribute to scientific publications and articles, showcasing trial data and findings.
• Join a dynamic organization with two approved products and multiple candidates in late-stage development.

Associate Director of Biostatistics Key Responsibilities & Duties

• Represent biostatistics in cross-functional meetings to drive clinical development strategies for drug candidates.
• Collaborate with Clinical Development, Regulatory, and Operations teams to design and implement clinical trials.
• Develop statistical sections for clinical trial protocols and contribute to statistical analysis plans.
• Provide statistical guidance on trial conduct, ensuring adherence to regulatory standards and scientific rigor.
• Collaborate with Data Management and Statistical Programmers on data summary and analysis.
• Prepare regulatory documents, including clinical study reports, DSURs, and briefing documents.
• Manage CRO statistical and programming support to ensure project alignment and quality.
• Represent the client in regulatory meetings and interactions with international authorities.
• Contribute to scientific articles and publications summarizing trial data and findings.

Associate Director of Biostatistics Job Requirements

• PhD in Biostatistics, Statistics, Mathematics, Biology, or related field required.
• Minimum of seven years of experience in biostatistics or related roles within clinical development.
• Proficiency in SAS and R programming, Bayesian analysis, and dose-response modeling.
• Experience with clinical trials through Phase 3 and knowledge of ICH GCP guidelines.
• Familiarity with CDISC standards, including SDTM, ADaM, and CDASH frameworks.
• Demonstrated ability to design and conduct adaptive trials and interim analyses.
• Experience interacting with regulatory authorities, including the US FDA and international bodies.
• Strong communication skills to represent the client in meetings with stakeholders and regulators.
• Knowledge of advanced statistical software tools such as EAST.