Contractor - Associate Director Statistician - Remote

Role Description • Serve as the lead biostatistics representative on cross-functional clinical development teams, providing strategic statistical input across all phases of drug development. • Partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Statistical Programming, Data Management, Medical Writing, and Preclinical teams to design, analyze, and interpret clinical trials. • Lead the statistical design and analysis strategy for clinical studies, including sample size justification, endpoint selection, and statistical methodology. • Author and review statistical analysis plans (SAPs), protocol sections, and key outputs such as tables, figures, and listings (TFLs). • Provide statistical leadership for regulatory interactions, including health authority meetings, advisory committee presentations, and responses to regulatory questions. • Contribute to and lead process improvement initiatives, technical working groups, and cross-functional governance teams; establish timelines and ensure high-quality deliverables. • Evaluate and implement innovative statistical methodologies and assess the suitability of statistical software and tools for complex analyses. • Analyze and interpret time-to-event, longitudinal, and complex clinical data, ensuring robust and defensible conclusions. • Prepare and deliver presentations and written reports to project teams, senior management, and external stakeholders; co-present key findings when appropriate. • Participate in methodological research and innovation to advance statistical approaches in clinical trial development. • Provide statistical training and mentorship to non-statisticians and junior statisticians to promote data-driven decision-making. Qualifications • PhD in Statistics or Biostatistics with 5+ years of pharmaceutical or CRO industry experience or MS in Statistics or Biostatistics with 8+ years of relevant industry experience • Strong expertise in clinical trial design and statistical analysis methodologies • Proficiency in statistical software (e.g., SAS, R, or equivalent) • Knowledge of drug discovery and clinical development, including regulatory requirements • Experience in Neuroscience therapeutic area is preferred • Proven leadership and influencing skills within cross-functional teams • Strong critical thinking, problem-solving, and decision-making abilities • Excellent written and verbal communication skills, including communication with regulatory agencies • Ability to manage multiple priorities and perform effectively in a fast-paced, collaborative environment • Visa Sponsorship will not be provided for this position.