Gilead is looking to solve complex health challenges by developing life-changing therapies. This role is crucial for ensuring the statistical integrity and successful submission of clinical trial data for regulatory approval, contributing to the company's mission of creating a healthier world.
Requirements
- MS in biostatistics or related discipline with 8+ years of relevant experience in statistical analysis of biomedical data using SAS software.
- 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.
- Advanced knowledge of biomedical statistical analysis, biostatistics best practices, and tools, with demonstrated ability to apply these to improve results.
- Understanding of drug development phases, clinical trials, FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures.
- Advanced statistical software, methods, and techniques
- Statistical analysis principles, industry standards
Responsibilities
- Acting as the biostatistics lead for clinical studies or non-molecule projects, including statistical analysis, document review, and data inclusion for NDA submissions by collaborating with other biostatistics team members and cross-functional partners.
- Providing statistical consultation on trial design and study endpoints, authoring statistical analysis plans, and leading projects of increasing complexity or size.
- Overseeing and contributing to the completion of technical and operational statistical activities for groups of clinical trials, and directing teams in the definition, execution, and completion of statistical activities for molecules or marketed products.
- Advising partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results.
- Leading the gathering, organization, and analysis of data sources to deliver special projects and statistical analysis plans for assigned products.
- Reviewing and analyzing safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
- Using advanced statistical software, methods, and techniques to gather, analyze, and interpret research data for clinical development.
Other
- Minimum of 2 years of cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry, including multiple years of experience managing project teams.
- Proven effectiveness in managing projects and teams.
- Strategic thinking in advising on statistical requirements and opportunities to improve study or project outcomes.
- Strong communication and organizational skills, and ability to travel when needed
- People Leaders are the cornerstone to the employee experience at Gilead and Kite.
