Statistical Science Director Overview • As a Statistical Science Director, lead statistical strategies and technical activities in pharmaceutical development. • Collaborate across functions to design, deliver, and interpret data for regulatory submissions and governance committees. • Mentor and develop statistical staff, fostering technical expertise and professional growth within the team. • Apply novel statistical methodologies to address complex issues and enhance decision-making processes. • Represent the organization externally at conferences, workshops, and health authority interactions. • Contribute to the development plans, regulatory strategies, and health technology assessments for product indications. • Ensure statistical content quality for study designs, documents, delivery, interpretation, and submissions. • Lead global statistical strategies and direct project work delivered by internal and external teams. • Stay updated on statistical methodologies and implement innovative approaches in pharmaceutical research. Statistical Science Director Key Responsibilities & Duties • Lead statistical design and strategy for product development plans and regulatory submissions. • Provide statistical leadership and ensure compliance with standards and regulations. • Quantify benefit, risk, value, and uncertainty of emerging product profiles. • Collaborate with cross-functional teams to deliver high-quality decision support. • Mentor and coach statistical staff, promoting technical education and training. • Partner with CROs to ensure timely and quality delivery of statistical work. • Represent statistical strategy in internal governance and therapy area leadership teams. • Investigate and implement novel statistical approaches for regulatory and methodological advancements. • Maintain expertise in statistical methodologies and contribute to external collaborations and publications. Statistical Science Director Job Requirements • Doctorate in Statistics, Mathematics, or related field with substantial statistical components. • Minimum 5 years of experience in clinical trials and statistical leadership. • Proficiency in programming languages like SAS, R, and Python. • Recognized expertise in statistical methodologies and regulatory interactions. • Experience in vaccines and immunotherapy is preferred but not required. • Strong project management and communication skills for cross-functional collaboration. • Ability to lead and direct work across teams, ensuring quality and compliance. • National recognition as a statistical technical expert with relevant publications. • Experience in business development opportunities, such as in-licensing, is beneficial.