Gilead Sciences

Senior Manager, Biostatistics

Gilead Sciences

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $169,320 - $219,120 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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 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
  • May lead projects or activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting
  • 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
  • Participates in cross-functional clinical development planning and protocol design to provide biostatistical input
  • Advises internal and external partners on choice of statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results
  • Leads gathering, organization and analysis of different data sources to enable delivery of special projects and statistical analysis plans
  • 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
  • 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 by programming new techniques; maintains knowledge of current and emerging trends
  • Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation
  • Participates in or leads special projects (methodologies, processes, technology, SOP development) that benefit multiple Biostatistics team members
  • Provides matrix management to projects supported and defines required resources for assigned work
  • Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Requirements

  • 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
  • 2+ years of experience in autoimmune and/or oncology therapeutic areas (preferred)
  • Master’s degree and 6 years, or PhD and 2 years of industry experience within pharma and biotech (preferred)
  • 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
  • Advanced knowledge of biomedical statistical analysis, independence in designing, implementing, and managing multiple statistical analysis strategies, plans deliverables and resource management
  • Advanced knowledge of biostatistics best practices and tools and 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 typically used by Biostatistics
  • Proven effectiveness managing projects and teams
  • When needed, ability to travel