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, figures, listings) for study reports and integrated summaries.
Anticipates resource needs and directs the design and/or coding of analysis files.
Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
Provides primary and secondary programming support as needed.
Implements strategic initiatives.
Requirements
BS degree in Biostatistics/Computer Science or equivalent and 8+ years’ experience in pharma/biotech -OR
MS degree in Biostatistics/Computer Science or equivalent and 4+ years’ experience in pharma/biotech –OR
PhD degree in Biostatistics/Computer Sciences or equivalent 2+ years of experience in pharma/biotech
Excellent verbal and written communication skills and interpersonal skills are required.
Solid analytical skills with advanced knowledge of statistics.
Proven track record on multiple, time-sensitive, and complex tasks.
Thorough understanding of clinical trials design and reporting processes, as well as regulatory reporting requirements including electronic data submissions for multiple therapeutic areas, especially with FDA, PMDA, EMA, and other global agencies.
Experience with integrated analysis activities for FDA and rest of world submissions plus their post-filing activities.
Ability to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
Ability to resolve study related issues and conflicts within a therapeutic project.
Benefits
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.