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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
Associate Director, Statistical Programming
Job Responsibilities and Skills:
Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.
Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a therapeutic project.
Manage a team of diversified statistical programmers.
Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
Directs the design and/or coding of analysis files.
Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent.
Excellent verbal and written communication skills and interpersonal skills are required.
Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions with FDA, PMDA, and other global agencies.
Has hands-on and leading experience with regulatory submissions and post-filing activities such as FDA, EMA, PMDA filing, RtQs, and inspections.
Experience with and demonstrated ability to interact with others departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
Has the proven ability to anticipate and resolve study related issues and conflicts within a therapeutic project.
Experience with and proven ability in oversight or managing outsourced study.
Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines.
Has the ability to directly supervise personnel.
Manages critical deadlines, demonstrates ability to resolves issues, and ensures studies will be completed within designated timeframe.
Responsible for all statistical programming activities within a therapeutic project or equivalent.
Proven ability and Viewed as a key resource by more senior individuals on technical initiatives and may represent the Company on contracts.
Identifies and leads strategic initiatives for the programming group.
Serves as project leader on studies of greater complexity.
May attend CST (Clinical Sub- Team) meetings as a representative of Programming group
Typical Education and Experience:
10 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
8 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
2 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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