Associate Director, Statistical Programming

Gilead Sciences • Seattle, WA

452d • $173,910 - $225,060

About The Position

The Associate Director of Statistical Programming at Gilead Sciences is responsible for leading a team of statistical programmers to ensure timely and accurate statistical data analysis and reporting for clinical trials. This role involves collaboration with Clinical Development staff, oversight of programming deliverables, and management of resources within therapeutic projects. The position requires a strong understanding of clinical trial design, regulatory reporting, and the ability to resolve study-related issues effectively.

Requirements

• 10 years of experience with a BS degree in Biostatistics/Computer Science or equivalent.
• 8 years of experience with a MS degree in Biostatistics/Computer Science or equivalent.
• 2 years of experience with a PhD degree in Biostatistics/Computer Science or equivalent.
• Thorough understanding of clinical trials design and reporting process.
• Hands-on experience with regulatory submissions and post-filing activities.
• Proven ability to interact with other departments for statistical reports.
• Ability to create buy-in and support for initiatives.

Nice To Haves

• Experience with FDA, EMA, PMDA filing, RtQs, and inspections.
• Experience in managing outsourced studies.

Responsibilities

• Collaborate with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Generate or oversee the production of programming deliverables for study reports and integrated summaries.
• Anticipate resource needs and work with management and HR for long-term resource allocation.
• Manage a team of diversified statistical programmers.
• Ensure programming and documentation is consistent with departmental procedures.
• Direct the design and/or coding of analysis files.
• Provide primary and secondary programming support and harmonize strategic initiatives across a therapeutic area.
• Communicate effectively with excellent verbal and written skills.
• Understand clinical trials design and reporting process, including regulatory reporting requirements.
• Interact with other departments to define and produce user-defined statistical reports.
• Anticipate and resolve study-related issues and conflicts within a therapeutic project.
• Oversee or manage outsourced studies and negotiate timelines.
• Supervise personnel directly and manage critical deadlines.
• Lead statistical programming activities within a therapeutic project.
• Identify and lead strategic initiatives for the programming group.
• Serve as project leader on complex studies.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree