Gilead Sciences
Senior Manager, Biostatistics-Oncology
Gilead Sciences, San Francisco, California, United States, 94199
Gilead Sciences is a leading global biopharma company focused on discovering and developing therapies for serious diseases. We are seeking a Biostatistics Manager to support clinical development through rigorous statistical analyses and documentation.
Job Description With guidance, 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. You will provide statistical consultation on trial design and study endpoints, calculate sample size, author statistical analysis plans, and contribute biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory filings.
Key Responsibilities
Act as biostatistics lead on clinical studies or non‑molecule projects.
Lead statistical analysis, document review, and data inclusion for NDA submissions, collaborating with Biostatistics team members and cross‑functional partners.
Oversee functional statistical activities for a group of clinical trials, directing internal and external teams to define, execute, and complete statistical work for one or more molecules or marketed products.
Participate in cross‑functional clinical development planning, protocol design, and review discussions, providing biostatistical perspective and input.
Advise partners on statistical analysis strategies, measurement reliability, model identifiability, and interpretation of results.
Gather, organize, and analyze multiple data sources for special projects, statistical analysis plans, and study endpoints.
Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
Use advanced statistical software and methods to analyze research data for clinical development.
Plan and document computer data file structures; develop, program, manage, and maintain complex statistical databases; perform or supervise data entry.
Develop enhancements to statistical software, programming new techniques, and staying current with emerging trends.
Provide biostatistical input into documentation, publications, presentations, and regulatory files.
Participate in or lead special projects benefiting the Biostatistics team, including SOP development.
Provide matrix management to supported projects.
Independently define required resources for work, seeking advice as needed.
Adhere to regulatory requirements, statistical 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
Ph.D./Pharm.D. and 2 years of experience.
Preferred Qualifications
Ph.D. in biostatistics or related discipline, preferably with 4+ years’ experience in the biopharma industry.
MS in biostatistics or related discipline with 6+ years’ experience.
Multiple years of biostatistical experience, including leading small projects and teams.
Strong expertise in SAS and other statistical software.
Experience in developing software or tools for statistical analysis.
Proven project and team management effectiveness.
Fast learner with flexible, adaptable mindset across projects.
Advanced knowledge of statistical principles and best practices applied to achieve business outcomes.
Strategic thinking and ability to advise on statistical requirements and improvement opportunities.
Understanding of drug development phases and clinical trials across phases.
Knowledge of FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures.
Strong communication and organizational skills.
Willingness to travel as needed.
People Leader Accountabilities
Promote inclusion and diversity in team management.
Develop talent by coaching employees on performance and growth.
Empower teams by aligning goals, purpose, and organizational objectives, removing barriers and connecting them to the broader ecosystem.
Salary Range Other US Locations: $153,935.00 - $199,210.00. Bay Area: $169,320.00 - $219,120.00.
Compensation may also include discretionary annual bonus, stock‑based incentives, paid time off, and a benefits package.
Benefits Benefits include company‑sponsored medical, dental, vision, and life insurance plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. We foster an inclusive work environment and hire based on qualifications without discrimination on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or veteran status. Reasonable accommodations are provided as required.
Internal applicants should apply through the Internal Career Opportunities portal in Workday.
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Job Description With guidance, 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. You will provide statistical consultation on trial design and study endpoints, calculate sample size, author statistical analysis plans, and contribute biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory filings.
Key Responsibilities
Act as biostatistics lead on clinical studies or non‑molecule projects.
Lead statistical analysis, document review, and data inclusion for NDA submissions, collaborating with Biostatistics team members and cross‑functional partners.
Oversee functional statistical activities for a group of clinical trials, directing internal and external teams to define, execute, and complete statistical work for one or more molecules or marketed products.
Participate in cross‑functional clinical development planning, protocol design, and review discussions, providing biostatistical perspective and input.
Advise partners on statistical analysis strategies, measurement reliability, model identifiability, and interpretation of results.
Gather, organize, and analyze multiple data sources for special projects, statistical analysis plans, and study endpoints.
Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
Use advanced statistical software and methods to analyze research data for clinical development.
Plan and document computer data file structures; develop, program, manage, and maintain complex statistical databases; perform or supervise data entry.
Develop enhancements to statistical software, programming new techniques, and staying current with emerging trends.
Provide biostatistical input into documentation, publications, presentations, and regulatory files.
Participate in or lead special projects benefiting the Biostatistics team, including SOP development.
Provide matrix management to supported projects.
Independently define required resources for work, seeking advice as needed.
Adhere to regulatory requirements, statistical 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
Ph.D./Pharm.D. and 2 years of experience.
Preferred Qualifications
Ph.D. in biostatistics or related discipline, preferably with 4+ years’ experience in the biopharma industry.
MS in biostatistics or related discipline with 6+ years’ experience.
Multiple years of biostatistical experience, including leading small projects and teams.
Strong expertise in SAS and other statistical software.
Experience in developing software or tools for statistical analysis.
Proven project and team management effectiveness.
Fast learner with flexible, adaptable mindset across projects.
Advanced knowledge of statistical principles and best practices applied to achieve business outcomes.
Strategic thinking and ability to advise on statistical requirements and improvement opportunities.
Understanding of drug development phases and clinical trials across phases.
Knowledge of FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures.
Strong communication and organizational skills.
Willingness to travel as needed.
People Leader Accountabilities
Promote inclusion and diversity in team management.
Develop talent by coaching employees on performance and growth.
Empower teams by aligning goals, purpose, and organizational objectives, removing barriers and connecting them to the broader ecosystem.
Salary Range Other US Locations: $153,935.00 - $199,210.00. Bay Area: $169,320.00 - $219,120.00.
Compensation may also include discretionary annual bonus, stock‑based incentives, paid time off, and a benefits package.
Benefits Benefits include company‑sponsored medical, dental, vision, and life insurance plans.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. We foster an inclusive work environment and hire based on qualifications without discrimination on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or veteran status. Reasonable accommodations are provided as required.
Internal applicants should apply through the Internal Career Opportunities portal in Workday.
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