Gilead Sciences
Overview
Sr Manager, Biostatistics role at Gilead Sciences. 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 to develop therapies that help improve lives and ensure access to these therapies across the globe. We believe every employee deserves a great leader and strive to create an inclusive environment where employees feel empowered to fulfil their aspirations. As the Sr. Manager, Biostatistics you will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies, collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include statistical consultation on clinical development plans, trial design and endpoints, sample size calculations, authoring statistical analysis plans, and providing input into regulatory filings, publications and presentations. Depending on the area of assignment, you may lead projects or activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting. You will contribute to short- and long-range Biostatistics strategies, plans and infrastructure development across Biostatistics teams. Responsibilities
Act as biostatistics lead on clinical studies or other non-molecule projects. Lead statistical analysis, document review and data inclusion for NDA submissions; provide statistical consultation on trial design and endpoints; author statistical analysis plans. May lead projects or activities that are non-molecule based (Biostatistics tools, programming, centralized analyses and reporting). Oversee and contribute to completion of technical and operational statistical activities for a group of clinical trials; direct internal and external teams in statistical activities for one or more molecules or products. Participate in cross-functional clinical development planning to provide biostatistical perspective and input; participate in cross-functional protocol design and review discussions. Advise internal and external partners on statistical analysis strategies, measurement reliability and model identifiability; interpret and present statistical results. Gather, organize and analyze data from different sources to enable delivery of statistics plans and endpoints for assigned products. Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring. Use advanced statistical software, methods and techniques to analyze data for clinical development. Plan and document data file structures; develop, program, manage and maintain complex statistical databases; supervise data entry as needed. Develop enhancements to statistical software and stay current with trends in statistical methodologies and tools. Provide statistical input into clinical development documentation, publications, presentations and regulatory documentation. Participate in or lead special projects benefiting multiple Biostatistics team members and contribute to SOP development and related documentation. Provide matrix management to projects supported; independently define required resources for assigned work. Adhere to regulatory requirements, statistical principles, industry standards and Gilead SOPs. Minimum Education & Experience
Bachelor’s degree and 8 years of experience Master’s degree and 6 years of experience PhD/ PharmD (with respective years of experience) Preferred Education & Experience
Demonstrated ability to be a fast learner and adaptable to change; ability to move between projects and provide cross-functional support. Advanced knowledge of biomedical statistical analysis and independence in designing and managing multiple analysis strategies and resource management. Knowledge of biostatistics best practices, FDA/EMA regulations, ICH guidelines, GCP and clinical procedures. Strong communication and organizational skills. PhD in biostatistics or related discipline with 2+ years (PhD with 4+ years preferred) of SAS-based statistical analysis experience in biopharma or related environments; MS with 8+ years of SAS-based experience also acceptable. Cross-functional project management or leadership experience in biostatistics or related field (2+ years; several years preferred). Experience developing software/tools to support statistical analysis; proficiency with statistical software tools. Willingness to travel as needed. People Leader Accountabilities
Create Inclusion, Develop Talent, and Empower Teams by aligning goals, mentoring employees, and removing barriers to enable performance and growth. Compensation and Benefits
Salary range: $169,320.00 - $219,120.00. Eligible for discretionary bonus, stock-based long-term incentives (role dependent), PTO, and benefits including medical, dental, vision and life insurance. Visit the compensation, benefits and wellbeing page for details. Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. Employment decisions are made without discrimination based on protected characteristics. Applicants needing accommodations may contact ApplicantAccommodations@gilead.com. Refer to Know Your Rights for more information. For current employees, please apply via the Internal Career Opportunities portal in Workday.
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Sr Manager, Biostatistics role at Gilead Sciences. 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 to develop therapies that help improve lives and ensure access to these therapies across the globe. We believe every employee deserves a great leader and strive to create an inclusive environment where employees feel empowered to fulfil their aspirations. As the Sr. Manager, Biostatistics you will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies, collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include statistical consultation on clinical development plans, trial design and endpoints, sample size calculations, authoring statistical analysis plans, and providing input into regulatory filings, publications and presentations. Depending on the area of assignment, you may lead projects or activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting. You will contribute to short- and long-range Biostatistics strategies, plans and infrastructure development across Biostatistics teams. Responsibilities
Act as biostatistics lead on clinical studies or other non-molecule projects. Lead statistical analysis, document review and data inclusion for NDA submissions; provide statistical consultation on trial design and endpoints; author statistical analysis plans. May lead projects or activities that are non-molecule based (Biostatistics tools, programming, centralized analyses and reporting). Oversee and contribute to completion of technical and operational statistical activities for a group of clinical trials; direct internal and external teams in statistical activities for one or more molecules or products. Participate in cross-functional clinical development planning to provide biostatistical perspective and input; participate in cross-functional protocol design and review discussions. Advise internal and external partners on statistical analysis strategies, measurement reliability and model identifiability; interpret and present statistical results. Gather, organize and analyze data from different sources to enable delivery of statistics plans and endpoints for assigned products. Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring. Use advanced statistical software, methods and techniques to analyze data for clinical development. Plan and document data file structures; develop, program, manage and maintain complex statistical databases; supervise data entry as needed. Develop enhancements to statistical software and stay current with trends in statistical methodologies and tools. Provide statistical input into clinical development documentation, publications, presentations and regulatory documentation. Participate in or lead special projects benefiting multiple Biostatistics team members and contribute to SOP development and related documentation. Provide matrix management to projects supported; independently define required resources for assigned work. Adhere to regulatory requirements, statistical principles, industry standards and Gilead SOPs. Minimum Education & Experience
Bachelor’s degree and 8 years of experience Master’s degree and 6 years of experience PhD/ PharmD (with respective years of experience) Preferred Education & Experience
Demonstrated ability to be a fast learner and adaptable to change; ability to move between projects and provide cross-functional support. Advanced knowledge of biomedical statistical analysis and independence in designing and managing multiple analysis strategies and resource management. Knowledge of biostatistics best practices, FDA/EMA regulations, ICH guidelines, GCP and clinical procedures. Strong communication and organizational skills. PhD in biostatistics or related discipline with 2+ years (PhD with 4+ years preferred) of SAS-based statistical analysis experience in biopharma or related environments; MS with 8+ years of SAS-based experience also acceptable. Cross-functional project management or leadership experience in biostatistics or related field (2+ years; several years preferred). Experience developing software/tools to support statistical analysis; proficiency with statistical software tools. Willingness to travel as needed. People Leader Accountabilities
Create Inclusion, Develop Talent, and Empower Teams by aligning goals, mentoring employees, and removing barriers to enable performance and growth. Compensation and Benefits
Salary range: $169,320.00 - $219,120.00. Eligible for discretionary bonus, stock-based long-term incentives (role dependent), PTO, and benefits including medical, dental, vision and life insurance. Visit the compensation, benefits and wellbeing page for details. Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. Employment decisions are made without discrimination based on protected characteristics. Applicants needing accommodations may contact ApplicantAccommodations@gilead.com. Refer to Know Your Rights for more information. For current employees, please apply via the Internal Career Opportunities portal in Workday.
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