Senior Manager, Biostatistics-Oncology

Role Summary

Lead biostatistical analysis and reporting for oncology programs, including data review and NDA submission support. Collaborate with cross-functional partners to meet clinical development timelines, provide statistical input on trial design and endpoints, and contribute to regulatory filings, publications, and presentations. May lead non-molecule projects such as biostatistics tools, programming, and centralized analyses, depending on area of assignment.

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 regulatory filings and publications; may lead non-molecule projects.
• 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 molecules or products of increasing complexity.
• Participate in cross-functional clinical development planning and protocol design/review discussions to provide biostatistical input.
• Advise internal and external partners on analysis strategies, measurement reliability, model identifiability, and interpretation of results.
• Lead data gathering and analysis from multiple sources to support statistical analysis plans and endpoints for assigned products.
• Review and analyze safety reporting, biomarker analyses, and other trial monitoring aspects.
• Use advanced statistical software and methodologies to analyze data for clinical development.
• Plan, document and manage data file structures; develop and maintain statistical databases; supervise data entry when needed.
• Develop enhancements to statistical software and stay current with emerging methodologies and tools.
• Provide biostatistical input into clinical documentation, publications, presentations, and regulatory materials.
• Participate in or lead special projects across the Biostatistics team; contribute to SOPs and related documentation.
• Provide matrix management to projects; independently define required resources for assigned work.
• Adhere to regulatory requirements, study conduct guidelines, industry standards, and SOPs.

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: PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS; PhD with 4+ years’ biostatistics experience is preferred
• Preferred: MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis using SAS
• Preferred: Multiple years of biostatistics experience, including leading small projects and teams
• Preferred: Significant biomedical statistical analysis experience and proficiency with relevant software
• Preferred: Experience developing software/tools to support statistical analysis; strong proficiencies in statistical software
• Preferred: Proven ability to manage projects and teams; fast learner; adaptability to changing projects
• Preferred: Advanced knowledge of statistical principles and biostatistics best practices; ability to apply to achieve outcomes
• Preferred: Understanding of drug development phases, clinical trials across phases, and FDA/EMA regulations, ICH guidelines, GCP
• Preferred: Strong communication and organizational skills; ability to travel when needed

Skills

• Statistical analysis (biostatistics) and study design
• Proficiency with SAS and other statistical software
• Data management and database development
• Regulatory documentation and scientific communications

Education

• Bachelor’s, Master’s, or PhD/PharmD in a relevant field (biostatistics, statistics, or related)

Additional Requirements

• Ability to travel when needed