Manager, Biostatistics

Descripción del trabajo

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 a Manager, Biostatistics , at Gilead you will ...

Support 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 contribute to the projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. You will also contribute to short- and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics, such as team capability development.

Key responsibilities

• Provides support to 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. 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.
• Contributes to cross-functional clinical development planning for one or more molecules or marketed products; provide the biostatistical perspective and biostatistical input.
• Contributes to 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.
• Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development.
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Basic qualifications:

• 6+ Years of relevant experience with BS/BA in Biostatistics, Statistics, Mathematics, or a related quantitative discipline

OR

• MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline
  with 4+ years of relevant experience

Preferred Qualifications:

• PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 2+ years of relevant experience
• 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 knowledge of biomedical statistical analysis, best practices and tools and has shown ability to apply this to improve overall results.
• Understands drug development phases and the nature of associated clinical trials across phases.
• Strong communication and organizational skills.
• 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.
• 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.