Associate Director, Biostatistics

Role Summary

Lead biostatistical analysis and reporting for assigned clinical studies and projects, collaborating with cross-functional partners to meet development timelines. Provide statistical consultation on trial design, endpoints, and analysis plans; contribute to regulatory submissions, publications, and presentations. May lead non-molecule projects and contribute to long-range biostatistics strategy and infrastructure development across teams.

Responsibilities

• Act as the biostatistics lead for clinical studies or non-molecule projects, including statistical analysis, document review, and data inclusion for NDA submissions in collaboration with team members and cross-functional partners.
• Provide statistical consultation on trial design and study endpoints, author statistical analysis plans, and lead projects of increasing complexity or size.
• Oversee and contribute to technical and operational statistical activities for groups of clinical trials; direct teams in definition, execution, and completion of statistical activities for molecules or marketed products.
• Participate in cross-functional clinical development planning and protocol design discussions to provide biostatistical input.
• Advise partners on statistical analysis strategies, measurement reliability, identifiability of models, and interpretation/presentation of results.
• Lead gathering, organization, and analysis of data sources to deliver special projects and statistical analysis plans for assigned products.
• Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
• Use advanced statistical software, methods, and techniques to gather, analyze, and interpret data for clinical development.
• Plan and document computer data file structures, development, programming, managing, and maintaining complex statistical databases; supervise data entry when needed.
• Develop enhancements to statistical software and stay current with trends in statistical analysis methodologies and tools.
• Provide biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation.
• Participate in or lead special projects that benefit multiple team members, contribute to SOPs and related documentation, and support cross-team initiatives.
• Provide matrix management to supported projects and independently define required resources for assigned work.
• Adhere to regulatory requirements, statistical principles, industry standards, and company SOPs.

Qualifications

• PhD with 6+ years of biostatistics experience is preferred.
• MS in biostatistics or related discipline with 8+ years of relevant experience in statistical analysis of biomedical data using SAS software.
• Minimum of 2 years of cross-functional project management or leadership experience in biostatistics or related field in the biopharma industry, including multiple years of experience managing project teams.
• Significant biomedical statistical analysis experience and proficiency with relevant software and tools.
• Experience developing software and tools to support statistical analysis of biomedical or related data.
• Proven effectiveness in managing projects and teams.
• Advanced knowledge of biomedical statistical analysis, biostatistics best practices, and tools, with demonstrated ability to apply these to improve results.
• Strategic thinking in advising on statistical requirements and opportunities to improve study or project outcomes.
• Understanding of drug development phases, clinical trials, FDA/EMA regulations, ICH guidelines, GCP, and standard clinical procedures.
• Strong communication and organizational skills; ability to travel when needed.

Education

• PhD in Biostatistics or a related field (preferred).
• MS in Biostatistics or related discipline with substantial experience in statistical analysis of biomedical data using SAS software.

Additional Requirements

• Strong communication and organizational skills; ability to travel as required.