Statistical Science Director – Infectious Disease

Statistical Science Director – Infectious Disease Overview

• As a Statistical Science Director, lead statistical strategies for infectious disease projects, ensuring impactful contributions to pharmaceutical development and regulatory submissions.
• Collaborate with cross-functional teams to design and interpret data for governance committees and health technology assessments.
• Provide expert guidance in statistical methodologies, fostering innovation and excellence in clinical trial design and analysis.
• Mentor and develop statistical staff, enhancing technical expertise and promoting professional growth within the team.
• Represent the organization externally, contributing to advisory boards, conferences, and regulatory interactions.
• Stay abreast of industry advancements, implementing novel statistical approaches to address emerging challenges.
• Drive impactful decision-making by quantifying benefits, risks, and uncertainties of product profiles.
• Contribute to the development of life-changing medicines through innovative statistical leadership and collaboration.

Statistical Science Director – Infectious Disease Key Responsibilities & Duties

• Lead statistical strategy and content for product development plans, regulatory submissions, and health technology assessments.
• Ensure high-quality statistical design and delivery for clinical trials and preclinical studies.
• Collaborate with CROs to deliver projects on time and to quality standards.
• Mentor and coach statistical staff, fostering technical growth and team development.
• Represent statistical methodologies and strategies at internal governance boards and external forums.
• Investigate and implement novel statistical approaches to address regulatory and methodological challenges.
• Provide technical leadership across multiple studies, ensuring alignment and consistency in statistical practices.
• Contribute to publications and external collaborations, enhancing the organization's reputation in statistical innovation.

Statistical Science Director – Infectious Disease Job Requirements

• PhD in Statistics, Mathematics, or a related field with substantial statistical components.
• Minimum of 5 years of experience in clinical trials, with leadership capabilities.
• Proficiency in statistical programming languages such as SAS, R, and Python.
• Expertise in statistical methodologies and regulatory requirements within the pharmaceutical industry.
• Strong project management skills, ensuring effective collaboration and delivery.
• Experience in vaccines and immunotherapy is preferred but not mandatory.
• Demonstrated ability to lead cross-functional teams and mentor staff effectively.
• Recognition as a statistical expert through publications and external collaborations.