Gilead Sciences
Associate Director, Biostatistics
Gilead Sciences, Foster City, California, United States, 94420
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job Description
POSITION 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. Dependent upon the area of assignment, you may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. You will also contribute to short- and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics, such as team capability development.EXAMPLE RESPONSIBILITIES:
Acts as biostatistics lead on clinical studies or other non-molecule projects.Where applicable, 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.Where applicable, 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.Where applicable, participates in cross-functional clinical development planning to provide the biostatistical perspective and input.Where applicable, 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 interpretation of statistical results.Leads the gathering, organization and analysis of different data sources for assigned products.Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.Uses advanced statistical software, methods, and techniques to gather, analyze, and interpret research data.Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases.Develops enhancements to statistical software, as appropriate, by programming new techniques.Provides biostatistical input into clinical development documentation, scientific publications and presentations.May participate in or lead special projects that can benefit multiple Biostatistics team members.Provides matrix management to projects supported.Independently defines required resources for assigned work, seeking advice as needed.Adheres to regulatory requirements of study conduct and statistical analysis principles.REQUIREMENTS:
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
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.Significant biomedical statistical analysis experience and experience working with relevant software.Experience developing software and other tools to support statistical analysis of biomedical data.Proven effectiveness managing projects and teams.Knowledge & Other Requirements
Demonstrated ability to be a fast learner.Demonstrated ability to be flexible and adaptable to change.Has advanced knowledge of biomedical statistical analysis.Has advanced knowledge of biostatistics best practices and tools.Demonstrates strategic thinking in advising others on statistical requirements.Understands drug development phases and the nature of associated clinical trials.Knowledge of FDA and EMA regulations, ICH guidelines, GCP.Strong communication and organizational skills.When needed, ability to travel.The salary range for this position is: $191,335.00 - $247,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus and benefits package.For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeingAs 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.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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POSITION 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. Dependent upon the area of assignment, you may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. You will also contribute to short- and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics, such as team capability development.EXAMPLE RESPONSIBILITIES:
Acts as biostatistics lead on clinical studies or other non-molecule projects.Where applicable, 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.Where applicable, 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.Where applicable, participates in cross-functional clinical development planning to provide the biostatistical perspective and input.Where applicable, 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 interpretation of statistical results.Leads the gathering, organization and analysis of different data sources for assigned products.Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.Uses advanced statistical software, methods, and techniques to gather, analyze, and interpret research data.Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases.Develops enhancements to statistical software, as appropriate, by programming new techniques.Provides biostatistical input into clinical development documentation, scientific publications and presentations.May participate in or lead special projects that can benefit multiple Biostatistics team members.Provides matrix management to projects supported.Independently defines required resources for assigned work, seeking advice as needed.Adheres to regulatory requirements of study conduct and statistical analysis principles.REQUIREMENTS:
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
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.Significant biomedical statistical analysis experience and experience working with relevant software.Experience developing software and other tools to support statistical analysis of biomedical data.Proven effectiveness managing projects and teams.Knowledge & Other Requirements
Demonstrated ability to be a fast learner.Demonstrated ability to be flexible and adaptable to change.Has advanced knowledge of biomedical statistical analysis.Has advanced knowledge of biostatistics best practices and tools.Demonstrates strategic thinking in advising others on statistical requirements.Understands drug development phases and the nature of associated clinical trials.Knowledge of FDA and EMA regulations, ICH guidelines, GCP.Strong communication and organizational skills.When needed, ability to travel.The salary range for this position is: $191,335.00 - $247,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus and benefits package.For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeingAs 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.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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