Assoc. Director, Biostatistics

Associate Director, BiostatisticsWe are looking for an experienced Associate Director, Biostatistics to lead statistical strategy, analysis, and oversight for clinical development programs. This role supports high-profile projects while managing a team of biostatisticians to ensure the highest quality and compliance with regulatory standards.Key ResponsibilitiesStrategic Leadership:Collaborate with cross-functional teams to develop statistical strategies for clinical trials (Phases I-IV).Provide input on protocol design, sample size calculations, and endpoint selection.Contribute to regulatory submissions and respond to agency queries.Team Management & Mentorship:Lead and mentor a team of biostatisticians, fostering growth and professional development.Assign resources, delegate tasks, and monitor project progress.Conduct performance reviews, provide constructive feedback, and develop training plans.Operational Oversight:Oversee the development of statistical analysis plans (SAPs) and ensure timely, high-quality deliverables.Review and validate datasets, TLFs (tables, listings, figures), and statistical outputs.Collaborate with Data Management and Programming teams to ensure data integrity.Process Improvement & Innovation:Drive the development of SOPs and best practices for statistical methodologies.Stay updated on industry trends and innovative biostatistical approaches.Lead internal training and knowledge-sharing initiatives.Client Engagement & Business Development:Support proposal development, bid defenses, and client presentations.Build relationships with sponsors, providing statistical expertise and guidance.QualificationsMaster's or Ph.D. in Biostatistics, Statistics, or a related field.12+ years of experience in biostatistics for clinical trials, with at least 5 years in a leadership role.Expertise in statistical programming languages (e.g., SAS, R).In-depth knowledge of FDA, EMA, and ICH guidelines.Strong leadership, communication, and problem-solving skills.Proven ability to manage multiple projects and teams simultaneously.Join a team committed to driving innovation in biostatistics and advancing clinical research outcomes.

Created: 2025-01-14