Gilead Sciences, Inc.
Senior Manager, Biostatistics
Gilead Sciences, Inc., Santa Monica, California, United States, 90403
Senior Manager, Biostatistics
United States - California - Santa Monica, United States - California - Foster City Clinical Development & Clinical Operations Regular Job Description
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. 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. Typically assigned clinical studies or other projects of increasing complexity or size. Depending on area of assignment, may lead 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 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. 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 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. Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry. 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. 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. Minimum Education & Experience
Bachelor’s degree and 10 years of experience OR Master’s degree and 8 years of experience OR PhD/ PharmD and 2 years of experience Preferred Education & Experience
2+ years of experience in autoimmune and/or oncology therapeutic areas Master’s degree and 6 years, or PhD and 2 years of industry experience within pharma and biotech 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. 2+ years’ cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry or a related environment, including multiple years’ experience managing 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 related data. Strong proficiencies in software and other tools used typically used by Biostatistics. Proven effectiveness managing projects and teams. When needed, ability to travel. Salary
The salary range for this position is: Other US Locations: $153,935.00 - $199,210.00. Bay Area: $169,320.00 - $219,120.00. Kite 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. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system\'s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma . Equal Opportunity
For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all 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 origin, sex, 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 ApplicantAccommodations@gilead.com 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 PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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 make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday.
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United States - California - Santa Monica, United States - California - Foster City Clinical Development & Clinical Operations Regular Job Description
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. 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. Typically assigned clinical studies or other projects of increasing complexity or size. Depending on area of assignment, may lead 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 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. 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 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. Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry. 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. 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. Minimum Education & Experience
Bachelor’s degree and 10 years of experience OR Master’s degree and 8 years of experience OR PhD/ PharmD and 2 years of experience Preferred Education & Experience
2+ years of experience in autoimmune and/or oncology therapeutic areas Master’s degree and 6 years, or PhD and 2 years of industry experience within pharma and biotech 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. 2+ years’ cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry or a related environment, including multiple years’ experience managing 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 related data. Strong proficiencies in software and other tools used typically used by Biostatistics. Proven effectiveness managing projects and teams. When needed, ability to travel. Salary
The salary range for this position is: Other US Locations: $153,935.00 - $199,210.00. Bay Area: $169,320.00 - $219,120.00. Kite 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. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system\'s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma . Equal Opportunity
For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all 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 origin, sex, 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 ApplicantAccommodations@gilead.com 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 PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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 make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr