Associate Director Of Biostatistics Overview • The Associate Director of Biostatistics will lead statistical strategies for clinical and preclinical projects, ensuring high-quality and timely deliverables. • Collaborate with cross-functional teams to design studies and develop regulatory strategies, driving impactful decision-making processes. • Provide advanced statistical expertise to assess benefit-risk profiles and enhance therapeutic outcomes. • Mentor and develop statistical staff, fostering a culture of continuous learning and professional growth. • Ensure compliance with global regulatory and technical standards in statistical practices. • Contribute to the integration and interpretability of global data through standardization efforts. • Support health technology assessments and commercial activities with data-driven insights. • Drive innovation by applying novel statistical methodologies to complex challenges. Associate Director Of Biostatistics Key Responsibilities & Duties • Lead statistical contributions to study designs, development plans, and regulatory submissions. • Oversee statistical work within projects, including collaboration with CRO partners. • Evaluate and develop innovative design options to support data-driven decisions. • Quantify benefit-risk profiles and assess the value of therapeutic assets. • Apply advanced statistical techniques, including modeling and simulation, to enhance project outcomes. • Ensure statistical deliverables meet quality, regulatory, and timeline expectations. • Collaborate with cross-functional teams to address technical and regulatory requirements. • Mentor statistical staff, promoting skill development and knowledge sharing. Associate Director Of Biostatistics Job Requirements • Doctorate in Statistics, Biostatistics, or a related field with a strong statistical foundation. • Minimum of 3 years of experience in the pharmaceutical industry, focusing on statistical applications. • Proficiency in statistical programming languages such as R and SAS. • Expertise in Bayesian statistics and computational methods for data analysis. • Strong project management skills to coordinate statistical activities and team efforts. • Excellent communication skills to collaborate effectively with cross-functional teams. • Flexibility and organizational abilities to manage multiple priorities in a dynamic environment. • Familiarity with regulatory guidelines and technical requirements in biostatistics.