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About the role
- Lead biostatistical analysis and reporting for NDA submissions of clinical studies at Gilead. Collaborate with cross-functional teams to meet clinical development project deliverables and timelines.
Responsibilities
- Lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners
- Provide statistical consultation on clinical development plans, clinical trial design and clinical study endpoints
- Calculate sample size, authoring statistical analysis plans and provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings
- Oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials
- Direct internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products of increasing complexity
- Participate in cross-functional clinical development planning and protocol design and review discussions
- Advise internal and external partners on statistical analysis strategies, reliability of measurements and interpretation of statistical results
- Gather, organize and analyze different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products
- Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring
- Use advanced statistical software, methods, and techniques to analyze and interpret research data
- Plan and document computer data file structure; develop, program, manage, and maintain statistical databases; perform or supervise data entry
- Develop enhancements to statistical software, as appropriate, and maintain knowledge of current and emerging trends in statistical analysis methodologies and tools.
Requirements
- 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
- PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment
- PhD with 4+ years’ biostatistics experience is preferred
- MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software
- Multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams.
- 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.
- 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.
- Advanced knowledge of underlying statistical principles, concepts, practices, standards, processes and tools.
- Advanced knowledge of biostatistics best practices and tools and ability to apply this to improve overall results.
- Strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
- Strong communication and organizational skills.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
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