Gilead is looking for a Sr. Manager, Biostatistics to lead biostatistical analysis and reporting for NDA submissions, ensuring the accuracy and efficiency of clinical development projects and contributing to the company's mission of creating a healthier world.
Requirements
- PhD in biostatistics or related discipline with 2+ years’ relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry or a related environment.
- MS in biostatistics or related discipline with 8+ years’ relevant experience in statistical analysis of biomedical data using SAS software.
- Significant biomedical statistical analysis experience and experience working with relevant software.
- Experience developing software and other tools to support statistical analysis of biomedical or related data.
- Strong proficiencies in software and other tools used typically used by Biostatistics.
- Has advanced knowledge of biomedical statistical analysis, as evidenced by independence in designing, implementing and managing multiple statistical analysis strategies, plans deliverables and resource management.
- Has advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results.
Responsibilities
- Acts as biostatistics lead on clinical studies or other non-molecule projects.
- Where applicable, leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team members and cross-functional partners.
- Where applicable, oversees and contributes to completion of all technical and operational statistical activities for a group of clinical trials.
- Where applicable, participates in cross-functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical input.
- Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
- Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development.
- Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
Other
- Minimum of 2 years’ cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry or a related environment, including multiple years’ experience managing project teams.
- Proven effectiveness managing projects and teams.
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
