Associate Director, Biostatistics - Inflammation
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
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Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:
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to apply for this job.Job DescriptionAssociate Director, Biostatistics - InflammationPosition Overview:
Biostatisticians at Gilead work collaboratively with other functions to ensure appropriate design, statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory, scientific and business objectives. The Associate Director will be primarily responsible for the business, operational, and compliance aspects of respiratory/Inflammation drug development at Gilead. He/she will support respiratory/inflammatory mid through late stage drug development in one or more indications.Key Responsibilities:
Education & Experience
- Provides Statistical leadership to respiratory/inflammatory clinical trials: developing trial design options and providing high quality decision support.
- Is expected to oversee and contribute to the completion of all technical and operational statistical activities for the clinical trials and to defend statistical aspects with regulatory agencies.
- Works collaboratively with Statistical Programming, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management to meet project deliverables and timelines for statistical data analysis and reporting
- 10 years + (Bachelors); 8+ years (Masters); 6+ years (PhD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
- 5+ years of industry experience in the statistical analysis of clinical trial data using statistical software
- Extensive hands-on experience in drug development including design and analysis of phase 2/3 trials and active participation in NDA/BLA filing through label negotiation
- Demonstrated effective verbal and written communication skills and interpersonal skills are required
- Anticipates obstacles and difficulties and acts to meet goals
- Proven ability to design and use all available vehicles for effective scientific communication
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For Current Gilead Employees and Contractors:
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