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.