Associate Director, Biostatistics - Virology

仕事内容

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As an Associate Director, Biostatistics - Virology at Gilead you will ...

KEY RESPONSIBILITIES:

• Acts as biostatistics lead on clinical studies or other non-molecule projects.

• Where applicable, leads statistical analysis, document review and data inclusion for 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.

Basic Qualifications:

Bachelor’s degree and 10 years of experience

OR

Master’s degree and 8 years of experience

OR

PhD degree and 5 years of experience

Preferred Qualifications:

• 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.

• Experience developing software and other tools to support statistical analysis of biomedical or related data using R/Shiny. Strong proficiencies in software and other tools used typically used by Biostatistics.

• 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.

• Proven effectiveness managing projects and teams.

• When needed, ability to travel.

People Leader Accountabilities:

•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the

way they manage their teams.

•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current

performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and

realize their purpose.

•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding

them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.