Senior Director Biostatistics Late Infectious Disease
Senior Director Biostatistics Late Infectious DiseaseIntroduction to role:Are you ready to set the statistical direction for late-stage infectious disease programs and shape the evidence that delivers life-changing medicines to patients worldwide? In this high-impact leadership role, you will guide the design, analysis and interpretation of pivotal and life-cycle studies, transforming complex data into clear decisions that drive approvals, access and successful commercialization.You will lead a team of leaders, align Biostatistics strategy with enterprise priorities, and partner closely with Clinical, Regulatory, Medical and Data functions to accelerate timelines without compromising scientific rigor. Can you influence global strategy while coaching the next generation of statistical leaders, all while ensuring uncompromising data integrity and regulatory excellence?Accountabilities:- Biostatistics Strategy: Develop and implement the Biostatistics strategy for late-stage infectious disease, ensuring alignment with organizational objectives and portfolio priorities.- Portfolio Leadership: Manage global Biostatistics processes and systems, coordinate interfaces with global organizations, and lead a team of leaders to deliver across the portfolio.- Clinical Development Influence: Offer insights and recommendations to the global clinical development strategy across therapeutic areas, optimizing statistical considerations from study design to decision-making.- Regulatory Submissions: Define and contribute statistical findings and clinical data summaries; author key elements of regulatory submission dossiers; represent Biostatistics in health authority interactions.- Talent Development: Lead, mentor and develop the Biostatistics team; oversee the performance of senior managers; identify development opportunities; plan for succession to ensure leadership continuity.- Quality, Efficiency and Innovation: Direct initiatives that enhance quality, improve data integrity, optimize cost-efficiency and reduce timelines; where applicable, lead methodological or process innovations that deliver measurable business value.- Governance and Compliance: Ensure regulatory compliance and inspection readiness; uphold global standards, procedures and robust statistical practices throughout the development lifecycle.Essential Skills/Experience:Master's in Statistics or a related field; Recognized professional qualification; Expertise in biostatistics; Proven ability to lead functional and cross-functional teams; Demonstrated leadership in motivating and empowering teams; Comprehensive knowledge of drug development and commercialization processes; Capability to set and direct global priorities, resources, and projects; Experience managing teams in a global context; Strong conceptual and strategic thinking skills; Ability to strategically influence and tactfully persuade.Desirable Skills/Experience:PhD in a scientific discipline; Recognized expert with a strong reputation...