Associate Director Of Biostatistics

Associate Director of Biostatistics Overview

• The Associate Director of Biostatistics will lead statistical efforts in clinical development, collaborating across teams to design and analyze trials.
• Provide statistical expertise for clinical trial protocols, analysis plans, and regulatory documentation.
• Contribute to clinical study reports and scientific articles summarizing trial data.
• Collaborate with cross-functional teams including Clinical Development, Regulatory, and Clinical Operations.
• Manage statistical programming support and ensure compliance with regulatory standards.
• Represent the organization in regulatory meetings and interactions with key stakeholders.
• Join a global organization with a strong pipeline of innovative products and a collaborative culture.
• Contribute to impactful projects in a remote role with opportunities for professional growth.

Associate Director of Biostatistics Key Responsibilities & Duties

• Represent biostatistics in cross-functional team meetings to drive clinical development strategies.
• Design clinical trials and write statistical sections of protocols in collaboration with internal and external experts.
• Prepare statistical analysis plans and provide guidance on trial conduct and data management.
• Collaborate with programmers on data summary and analysis, ensuring accuracy and compliance.
• Contribute to regulatory documents, including DSURs and briefing documents, for submission.
• Manage CRO statistical and programming support to ensure project timelines and quality.
• Participate in scientific publications and presentations to share trial data insights.
• Consult with research teams on statistical methodologies and adaptive trial designs.

Associate Director of Biostatistics Job Requirements

• PhD in Biostatistics, Statistics, Mathematics, Biology, or related field.
• Minimum of 7 years of experience in clinical development through Phase 3.
• Proficiency in SAS programming, Bayesian analysis, and dose-response modeling.
• Experience with ICH GCP, adaptive trials, and regulatory interactions.
• Knowledge of CDISC standards (SDTM, ADaM, CDASH) and statistical software like R and EAST.
• Strong communication skills for collaboration and representation in regulatory meetings.
• Ability to manage CRO support and ensure project deliverables meet quality standards.
• Remote work flexibility with occasional travel to headquarters as needed.