About this role
Assoc Director, Statistical Programming
We are in search of an Associate Director, Statistical Programming to join our team! Statistical Programming– Analysis Programming: 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. This is a HYBRID position at our Foster City, CA OR Raleigh, NC locations. This is NOT a fully remote position.
Job 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.
- Anticipates resource needs.
- 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 for multiple therapeutic areas with FDA, PMDA, and other global agencies.
- Has extensive hands-on experience with regulatory submissions including integrated analysis and post-submission activities such as FDA and PMDA filing, RtQs, AdCom pre