Senior Manager, Biostatistics-Oncology

Role Summary

Senior Manager, Biostatistics-Oncology. Lead biostatistical analysis, reporting, and data inclusion for NDA submissions of assigned studies, collaborating with cross-functional partners to meet clinical development deliverables and timelines. Provide statistical consultation on trial design, endpoints, and regulatory filings. May lead non-molecule projects such as Biostatistics tools, programming, centralized analyses, and reporting.

Responsibilities

• With guidance, act as biostatistics lead on clinical studies or other non-molecule projects.
• Lead statistical analysis, document review and data inclusion for NDA submissions of assigned studies; provide statistical consultation on trial design and study endpoints; author statistical analysis plans; contribute to clinical development documentation, publications, and regulatory filings.
• Oversee and contribute to completion of technical and operational statistical activities for a group of clinical trials; direct internal and external teams in statistical activities for one or more molecules or marketed products.
• Participate in cross-functional clinical development planning and protocol design/review discussions to provide biostatistical input.
• Advise internal and external partners on statistical analysis strategies, measurement reliability, model identifiability, and interpretation/presentation of results.
• Gather, organize, and analyze data sources to enable delivery of special projects and/or the statistical analysis plan and endpoints.
• Review and analyze safety reporting, biomarker analyses, and other aspects of trial monitoring.
• Apply advanced statistical software and methods to gather, analyze, and interpret data for clinical development.
• Plan and document data file structures; develop, program, manage, and maintain complex statistical databases; supervise data entry.
• Develop enhancements to statistical software; stay informed on current and emerging trends in statistics.
• Provide biostatistical input into development documentation, publications, presentations, and regulatory documentation.
• Lead or participate in special projects benefiting multiple Biostatistics team members; contribute to SOP development and related documentation.
• Provide matrix management to projects supported; independently define required resources for assigned work.
• Adhere to regulatory requirements and SOPs for study conduct and statistical analysis.

Qualifications

• Required: Bachelor’s degree and 8 years of experience
• Required: Master’s degree and 6 years of experience
• Required: PhD/PharmD and 2 years of experience

Preferred Qualifications

• PhD in biostatistics or related discipline with relevant biomedical data analysis experience using SAS; 4+ years’ biostatistics experience preferred.
• MS in biostatistics or related discipline with 6+ years’ relevant SAS experience.
• Experience leading small projects and project teams; strong biomedical statistical analysis experience.
• Experience developing software/tools to support statistical analysis; proficiency with relevant software.
• Proven project and team management abilities; fast learner; adaptable to change.
• Advanced knowledge of statistical principles, practices, standards, processes, and tools; capability to apply to business needs.
• Strategic thinking in advising on statistical requirements; understanding of drug development and clinical trial phases.
• Knowledge of FDA/EMA regulations, ICH guidelines, GCP; strong communication and organizational skills.
• Ability to travel when needed.