Associate Biostatistics Director

Associate Biostatistics Director

Requirements

• PhD in biostatistics or related discipline with 2+ years’ relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry or a related environment. PhD with 4+ years’ biostatistics experience is preferred.
• MS in biostatistics or related discipline with 8+ years’ relevant experience in statistical analysis of biomedical data using SAS software.
• Minimum of 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 used typically used by Biostatistics.
• Proven effectiveness managing projects and teams.
• 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.
• Has advanced knowledge of biomedical statistical analysis, as evidenced by independence in designing, implementing and managing multiple statistical analysis strategies, plans deliverables and resource management.
• Has advanced knowledge of biostatistics best practices and tools and has shown 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.
• When needed, ability to travel.

Responsibilities

• Acts as biostatistics lead on clinical studies or other non-molecule projects.
• Where applicable, 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. Depending on area of assignment, may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.
• Where applicable, 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 of increasing complexity.
• Where applicable, participates in cross-functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical input.
• Where applicable, participates in cross-functional protocol design and review discussions.
• Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Leads the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products.
• 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 to derive useful information for clinical development.
• 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, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodologies and tools.
• Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
• May participate in or lead special projects that can benefit multiple Biostatistics team members, such as new methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation.
• Provides matrix management to projects supported.
• Independently defines required resources for assigned work, seeking advice as needed.
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Preferred Qualifications

• PhD with 4+ years’ biostatistics experience is preferred.