Overview In this role you guide statistical programming efforts to support regulatory, scientific, and business objectives. You will collaborate with Clinical Development and external vendors to deliver analysis datasets and outputs for study reports and integrated summaries. You'll lead design, coding, and documentation of analysis files, while driving process improvements across therapeutic areas. Your work will involve regulatory submissions, inspections readiness, and cross functional coordination to ensure timely, high quality deliverables. This is a pivotal leadership position at Gilead, offering impact on pivotal programs and global regulatory activities.
Compensation / Benefits- discretionary bonus
- discretionary stock-based long-term incentives
- paid time off
- medical insurance
- dental insurance
- vision insurance
Responsibilities- Collaborate with Clinical Development to meet timelines for data analysis and reporting
- Produce or oversee programming deliverables (tables, listings) for study reports and integrated summaries
- Anticipate resource needs and ensure documentation complies with procedures
- Direct design/coding of analysis files and provide programming support as needed
- Harmonize strategic initiatives across therapeutic areas and drive process improvements
- Communicate effectively with stakeholders and manage cross department interactions
- Understand regulatory reporting requirements across FDA, PMDA, and global agencies
- Lead or support regulatory submissions including integrated analyses and pre/post submission activities
- Resolve study level issues and negotiate timelines to meet critical deadlines
- Identify and lead strategic programming initiatives
- Manage multiple time sensitive tasks as a key resource
Key requirements- BS in Biostatistics/Computer Science or equivalent with 10+ years in pharma/biotech
- MS in Biostatistics/Computer Science or equivalent with 8+ years in pharma/biotech
- PhD in Biostatistics/Computer Science or equivalent with 3+ years in pharma/biotech
- excellent verbal and written communication
- interpersonal skills
- problem solving
- SAS programming with SAS Macros
- CDISC standards (CDASH, SDTM, ADaM)
- regulatory submission knowledge
