Associate Director - Biostatistics - Clinical Drug Dev
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
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Job DescriptionPosition Location
: Foster City, CA or Seattle, WAPOSITION OVERVIEW:
With increasing independence, you will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings.. You will also contribute to short- and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics. EXAMPLE RESPONSIBILITIES:
- Acts as biostatistics lead on clinical studies.
- 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. Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing complexity or size.
- Oversees and contributes to completion of all technical and operational statistical activities for a group of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products of increasing complexity.
- Participates in cross-functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical input.
- Participates in cross-functional protocol design and review discussions.
- Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
- Leads the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products.
- 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.
- Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodologies and tools.
- Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
- May participate in or lead special projects that can benefit multiple Biostatistics team members, such as new methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation.
- Provides matrix management to projects supported.
- Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Minimum Education & Experience
Knowledge & Other 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. PhD with 4+ years' biostatistics experience is preferred.
- MS in biostatistics or related discipline with 8+ years' relevant experience in statistical analysis of biomedical data using SAS software.
- 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.
- Significant biomedical statistical analysis experience and experience working with relevant software.
- Strong proficiencies in software and other tools used typically used by Biostatistics.
- 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.
- 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.
- Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
- Understands drug development phases and the nature of associated clinical trials across phases.
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
- Strong communication and organizational skills.
- When needed, ability to travel.
The salary range for this position is: $185,895.00 - $240,570.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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