Kite Pharma
Overview
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Senior Manager, Biostatistics
role at
Kite Pharma .
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.
Job Description
As the
Sr. Manager, Biostatistics , 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. Depending on 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.
Responsibilities
Acts as biostatistics lead on clinical studies or other non-molecule projects.
Leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies; collaborates with Biostatistics team members and cross-functional partners; provides statistical consultation on trial design and endpoints; authors statistical analysis plans; may lead non-molecule projects (e.g., Biostatistics tools, programming, centralized analyses and reporting).
Oversees and contributes to completion of technical and operational statistical activities for a group of clinical trials; directs internal and external teams for defined products.
Participates in cross-functional clinical development planning and protocol design discussions to provide biostatistical input.
Advises on choice of statistical analysis strategies, measurement reliability, model identifiability, and interpretation of results.
Gathers, organizes and analyzes diverse data sources to enable delivery of statistical analysis plans and trial endpoints.
Reviews and analyzes safety reporting, biomarker analyses and other aspects of trial monitoring.
Uses advanced statistical software and techniques to analyze data for clinical development.
Plans and documents data file structures; develops, programs, manages, and maintains statistical databases; may supervise data entry.
Develops enhancements to statistical software and stays current with emerging methodologies and tools.
Provides biostatistical input into clinical documentation, publications, presentations and regulatory filings.
Participates in special projects to benefit multiple Biostatistics team members and may contribute to SOPs and related documentation.
Provides matrix management to projects supported and defines required resources for assigned work.
Adheres to regulatory requirements, statistical principles, industry standards and SOPs.
Minimum Education & Experience
Bachelor’s degree and 10 years of experience
Master’s degree and 8 years of experience
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 and adaptable to change
Advanced knowledge of biomedical statistical analysis and independence in designing and managing multiple strategies and resources
Knowledge of FDA/EMA regulations, ICH guidelines, GCP and standard clinical procedures
Strong communication and organizational skills
2+ years’ cross-functional project management or leadership experience in biostatistics or related field
Experience developing software/tools to support statistical analysis
Proven ability to manage projects and teams; willingness to travel if needed
Compensation & Benefits 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 location. This position may be eligible for a discretionary annual bonus, stock-based long-term incentives, paid time off, and a benefits package. Benefits include medical, dental, vision, and life insurance plans. For more information, visit the Kite Careers benefits page.
Equal Opportunity Kite is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or other legally protected characteristics. Applicants requiring accommodation for the job application process may contact ApplicantAccommodations@gilead.com.
For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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Senior Manager, Biostatistics
role at
Kite Pharma .
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.
Job Description
As the
Sr. Manager, Biostatistics , 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. Depending on 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.
Responsibilities
Acts as biostatistics lead on clinical studies or other non-molecule projects.
Leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies; collaborates with Biostatistics team members and cross-functional partners; provides statistical consultation on trial design and endpoints; authors statistical analysis plans; may lead non-molecule projects (e.g., Biostatistics tools, programming, centralized analyses and reporting).
Oversees and contributes to completion of technical and operational statistical activities for a group of clinical trials; directs internal and external teams for defined products.
Participates in cross-functional clinical development planning and protocol design discussions to provide biostatistical input.
Advises on choice of statistical analysis strategies, measurement reliability, model identifiability, and interpretation of results.
Gathers, organizes and analyzes diverse data sources to enable delivery of statistical analysis plans and trial endpoints.
Reviews and analyzes safety reporting, biomarker analyses and other aspects of trial monitoring.
Uses advanced statistical software and techniques to analyze data for clinical development.
Plans and documents data file structures; develops, programs, manages, and maintains statistical databases; may supervise data entry.
Develops enhancements to statistical software and stays current with emerging methodologies and tools.
Provides biostatistical input into clinical documentation, publications, presentations and regulatory filings.
Participates in special projects to benefit multiple Biostatistics team members and may contribute to SOPs and related documentation.
Provides matrix management to projects supported and defines required resources for assigned work.
Adheres to regulatory requirements, statistical principles, industry standards and SOPs.
Minimum Education & Experience
Bachelor’s degree and 10 years of experience
Master’s degree and 8 years of experience
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 and adaptable to change
Advanced knowledge of biomedical statistical analysis and independence in designing and managing multiple strategies and resources
Knowledge of FDA/EMA regulations, ICH guidelines, GCP and standard clinical procedures
Strong communication and organizational skills
2+ years’ cross-functional project management or leadership experience in biostatistics or related field
Experience developing software/tools to support statistical analysis
Proven ability to manage projects and teams; willingness to travel if needed
Compensation & Benefits 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 location. This position may be eligible for a discretionary annual bonus, stock-based long-term incentives, paid time off, and a benefits package. Benefits include medical, dental, vision, and life insurance plans. For more information, visit the Kite Careers benefits page.
Equal Opportunity Kite is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or other legally protected characteristics. Applicants requiring accommodation for the job application process may contact ApplicantAccommodations@gilead.com.
For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr