Senior Manager, Biostatistics-Oncology

Role Summary

Lead biostatistical analysis and reporting 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, sample size, and regulatory documentation; may lead non-molecule projects such as Biostatistics tools, programming, centralized analyses, and reporting.

Responsibilities

• With guidance, acts 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; may lead non-molecule projects such as Biostatistics tools, programming, centralized analyses and reporting.
• Oversee and contribute to 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 to provide biostatistical perspective and input.
• Participate in cross-functional protocol design and review discussions.
• Advise internal and external partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation/presentation of results.
• Lead gathering, organization and analysis of data sources to enable delivery of special projects and / or statistical analysis plans and endpoints.
• Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
• Use advanced statistical software and methods to analyze data and support clinical development.
• Plan and document data file structures; develop, program, manage, and maintain complex statistical databases; perform or supervise data entry.
• Develop enhancements to statistical software and stay current with emerging methodologies and tools.
• Provide biostatistical input into clinical development documentation, publications and regulatory documentation.
• Participate in or lead special projects benefiting multiple Biostatistics team members; contribute to SOPs and related documentation.
• Provide matrix management to projects supported; independently define required resources for assigned work.
• Adhere to regulatory requirements, statistical principles, industry standards and Gilead SOPs.

Qualifications

• Required: Bachelor’s degree and 8 years of experience
• OR Master’s degree and 6 years of experience
• OR 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 in biopharma/healthcare/consulting/academia; PhD with 4+ years’ biostatistics experience preferred.
• MS in biostatistics or related discipline with 6+ years’ relevant experience using SAS.
• Experience leading small projects and project teams; extensive biomedical statistical analysis experience; proficient in relevant software and tools.
• Experience developing software/tools to support statistical analysis; strong communication and organizational skills.
• Ability to travel when needed.

Education

• No separate education section beyond qualifications; listed above.

Additional Requirements

• When needed, ability to travel.