Sr. Manager, Biostatistcs
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. Gileads 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 companys five core values. Thats 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.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Title: Senior Manager, Biostatistics
Location: United States - California - Foster City
Biostatisticians work collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of Gilead clinical data to efficiently achieve regulatory, scientific and business objectives.
The purpose of this role is to utilize statistical expertise and trial design experience to creatively solve meaningful problems and build effective solutions to improve the clinical drug development process. This role will involve a wide range of responsibilities including research and application of novel statistical methodologies, design and development of innovative analytical tools, and support of on-going clinical trials as a study statistician.Job Responsibilities
Education, Experience, & Skills:
- Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers, Data Scientists, Information & Systems, and other Clinical, Global Drug Safety, Regulatory, IT, and Project Management staff to meet project deliverables and timelines
- Provides statistical expertise and input to drug development programs. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value
- Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
- Supports technical reports and publications, ensures the timely delivery of statistical study results.
- Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
- Research statistical methodologies to more effectively analyze clinical trial data to improve decision making with an immediate focus on centralized statistical monitoring
- Explores opportunities to apply newer analytical techniques, e.g. machine learning and deep learning for classification, prediction, image detection, and/or natural language processing
- Design, prototype, and build software tools to empower study teams including data visualizations, clinical trial design and simulations, and/or exploratory study data analyses
Excellent verbal and written communication skills and interpersonal skills Deep and broad knowledge of current statistical methods, along with understanding of industry practices related to drug development
Must have experience with statistical simulation and modeling, and analysis of clinical trial data
Advanced R programming skills with hands-on experience with Shiny application development
Highly motivated problem solver interested in innovation and process improvement
Able to independently perform research to find creative solutions to complicated problems
Can present complex concepts and thinking in a concise and clear manner to others
Team player capable of leading and collaborating effectively with internal and external cross-functional teams
8+ years of industry experience in clinical trials and a BS degree in Biostatistics or equivalent.
6+ years of industry experience in clinical trials and an MS degree in Biostatistics or equivalent
4+ years of industry experience in clinical trials and an PhD degree in Biostatistics or equivalent
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2484773&targetURL=mailto:firstname.lastname@example.org">email@example.com for assistance.
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For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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