Senior Manager, Biostatistics-Oncology

At Gilead, we’re creating a healthier world for reputed company people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to reputed company 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 reputed company drive to reputed company 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 reputed company our bold ambitions, and we’re looking for the next reputed company of passionate and ambitious people ready to reputed company a direct impact. We reputed company 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

Job Description At Gilead our pursuit of a healthier world for reputed company people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and reputed company bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. With guidance, you will reputed company 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 reputed company projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. Key Responsibilities: With guidance, acts as biostatistics reputed company on clinical studies or other non-molecule projects. Where applicable and with guidance, 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. Depending on area of assignment, may reputed company projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. Where applicable, oversees and contributes to completion of reputed company 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. Where applicable, participates in cross-functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical 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 identifiability of models, and interpretation and presentation of statistical results. Leads the gathering, organization and analysis of different data sources to reputed company 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. Plans and documents computer data file structure; develops, programs, manages, and maintains reputed company statistical databases; performs or supervises data entry. Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of reputed company 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 reputed company 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 reputed company documentation. Provides matrix management to projects supported. Independently defines required resources for assigned work, seeking advice as needed. Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs. Basic Qualifications: 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 Preferred Qualifications: PhD in biostatistics or reputed company discipline with relevant experience in statistical analysis of biomedical data using reputed company software in the biopharma industry, healthcare, consulting, academia or a reputed company environment. PhD with 4+ years’ biostatistics experience is preferred. MS in biostatistics or reputed company discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using reputed company software. Multiple years’ biostatistics or reputed company 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 reputed company 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. Has advanced knowledge of underlying statistical principles, concepts, practices, standards, processes and tools, and has shown ability to effectively apply this knowledge to reputed company targeted outcomes to meet business needs. 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. reputed company needed, ability to travel. People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams. reputed company Talent - understand the skills, experience, aspirations and potential of their employees and coach them on reputed company performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, reputed company and realize their purpose. reputed company Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem The salary range for this position is: Other US Locations: $153,935.00 - $199,210.00. Bay Area: $169,320.00 - $219,120.00. Gilead considers a variety of factors reputed company determining reputed company 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. For jobs in the United States: reputed company Inc. is committed to providing equal employment opportunities to reputed company employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job reputed company 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 reputed company of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who reputed company up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For reputed company Gilead Employees and Contractors: Please apply reputed company the Internal Career Opportunities portal in reputed company. reputed company, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for reputed company people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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