Manager, Statistical Programming

Job Description

Primarily responsible for the business, operational, and compliance aspects of drug discovery, development, and marketed products at Gilead.
Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives.

Key Skills
 

• Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Generates or oversees the production of statistical output (e.g., tables, listings) for study reports and integrated summaries.
• Actively share experience and discuss possible process enhancements at programming meetings.
• Recommends potential trainings.
• Responsibilities:
• 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.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Is responsible for all programming activities within a therapeutic project or equivalent.
• Implements strategic initiatives.
• Must be able to lead and manage multiple concurrent projects.
• 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.
• Has the ability to resolve study related issues and conflicts within a therapeutic project.
• Can create buy-in and support and has the ability to negotiate timelines.
  
   

Education and Experience
 

• 7 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
• 5 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.