Associate Director, Biostatistics

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

With increasing independence, 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. 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.

The Associate Biostatistics Director is responsible for leading biostatistics activities on clinical studies and other projects. Key responsibilities include:

• Acting as the biostatistics lead for clinical studies or non-molecule projects, including statistical analysis, document review, and data inclusion for NDA submissions by collaborating with other biostatistics team members and cross-functional partners.

• Providing statistical consultation on trial design and study endpoints, authoring statistical analysis plans, and leading projects of increasing complexity or size.

• Overseeing and contributing to the completion of technical and operational statistical activities for groups of clinical trials, and directing teams in the definition, execution, and completion of statistical activities for molecules or marketed products.

• Participating in cross-functional clinical development planning and protocol design discussions to provide biostatistical input.

• Advising partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results.

• Leading the gathering, organization, and analysis of data sources to deliver special projects and statistical analysis plans for assigned products.

• Reviewing and analyzing safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.

• Using advanced statistical software, methods, and techniques to gather, analyze, and interpret research data for clinical development.

• Planning and documenting computer data file structures, development: Message, programming, managing, and maintaining complex statistical databases, and performing or supervising data entry.

• Developing enhancements to statistical software and maintaining knowledge of current and emerging trends in statistical analysis methodologies and tools.

• Providing biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation.

• Participating in or leading special projects that benefit multiple team members, such as new methodologies, processes, technology, and tools, and contributing to the development and implementation of SOPs and related documentation.

• Providing matrix management to supported projects and independently defining required resources for assigned work.

• Adhering to regulatory requirements, statistical analysis principles, industry standards, and company SOPs.

Qualifications: