Duties: 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. 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 lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc
Requirements: PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment. PhD with 2+ years’ biostatistics experience is preferred; MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software; Multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams; Significant biomedical statistical analysis experience and experience working with relevant software

Duties: Will be part of a highly effective team of Biomarker Clinical Programmers. Work collaboratively with Biomarker Clinical Data Associates, Biomarker Statistical Programmers, Bioinformatics, Biomarker Scientists and Biomarker/BioAnalytical Operations to meet project deliverables. Work with internal colleagues, offshore resources, and external vendors to ensure efficient, high-quality production of curated data for downstream use in sample tracking, production of statistical outputs for clinical study reports, biomarker analysis reports in support of Gilead’s regulatory, scientific, and business objectives
Requirements: 6 years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent; Experience in SAS programming required; Experience with Python strongly preferred

Duties: Develop and apply statistical and computational tools to analyze large scale omics and high dimensional data from internal, publicly available, commercial, and real-world datasets to enable novel target identification, target assessment, MoA elucidation, drug combination rationale, and patient stratification, etc; Design and apply statistical techniques and machine learning algorithms to enable the discovery and evaluation of preclinical predictive and prognostic biomarkers for oncology projects; Collaborate with cross-functional teams to analyze and interpret complex large datasets and efficiently communicate findings to non-computational scientists and senior leaders
Requirements: A PhD in bioinformatics, computational biology, biostatics, cancer genomics, or a related field with at least 5 years of relevant work experience. Industry experience is preferred; Excellent interpersonal and communication skills that foster collaboration and teamwork; Basic understanding of cancer biology, immunology, molecular and cell biology; Proficiency in R, Python, Perl, JAVA, or C/C++ programming languages

Duties: Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers, Data Scientists, Dev Systems, and other Clinical, Global Drug Safety, Regulatory, IT, and Project Management staff to deliver on cross-functional initiatives and projects; Research and support the implementation of innovative trial designs by exploring statistical methodologies, understanding industry best practices, sharing knowledge with cross-functional teams, and supporting the design of innovative trials; Serve as a statistical expert for risk-based quality management, with a focus on developing centralized statistical monitoring methods, tools, and processes; Design, prototype, and build tools to empower study teams including analytical dashboards, trial simulation packages, data visualizations, and automated workflows
Requirements: 8+ years of industry experience in clinical trials and a BS degree in Biostatistics or equivalent; Strong background in statistics, programming, and data analysis; Hands-on trial statistician experience with trial design, conduct, analysis, and reporting; Deep and broad knowledge of current statistical methods and drug development best practices; Expert in R and Python including experience with statistical simulations, package and Shiny development, and machine learning or AI-related use cases

Duties: Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support; Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head; Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting
Requirements: 12 years + (Bachelors); 10+ years (Masters); 8+ years (PhD); 4+ years (MD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO); Industry experience in the statistical analysis of biomedical data using statistical software; Extensive hands-on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation

Duties: Provide deep expertise in statistical and ML methods, and applications to accelerate research discovery; Establish and drive external collaborations in cutting-edge analytical method development and technology platforms; Collaborate with cross-functional teams to identify, evaluate, and deliver solutions to support Gilead Research objectives; Hands-on analysis of internal and external datasets and development of AI/ML models to support decision making and scientific insights; Collaborate cross therapeutic areas to deliver impact on research programs, examples including but not limited to statistical modeling of TCR repertoires, deep learning for peptide-MHC-binding and antigen epitopes predictions, etc
Requirements: PhD in computational biology, computer science, data science, physical science, statistics, or a related field with a minimum of 10+ years of relevant work experience. Industry experience and people management experience is preferred; Demonstrated track record and expertise in AI/ML method development and applications, e.g. deep neural networks, active learning, Bayesian optimization, LLM, etc; Excellent interpersonal and communication skills that foster collaboration and teamwork; Proficiency in R, Python, or C/C++ programming languages, shell scripting and command line tools

Duties: Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting; Generates or oversees the production of programming deliverables (e.g., tables, listings) for Oncology study reports and integrated summaries; Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within an Oncology project; May manage a small team of programmers; Designs and/or codes analysis files; Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures; Is responsible for all programming activities within an Oncology project or equivalent
Requirements: 8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent

Duties: Provide Statistical leadership to oncology clinical trials: developing trial design options and providing high quality decision support; Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to Biostatistics function TA leaders; Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management colleagues to meet project deliverables and timelines for statistical data analysis and reporting
Requirements: 10 years + (Bachelors); 8+ years (Masters); 2+ years (PhD): 0+ years (MD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO); Industry experience in the statistical analysis of biomedical data using statistical software; Extensive hands-on experience in oncology drug development including design and analysis of oncology trials and active participation in regulatory interaction