Associate Director, Statistical Programming - Oncology

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Job Description

Associate Director, Statistical Programming - Oncology

The position is site-based.

Job Responsibilities and Skills:

• 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 for clinical trials conducted at Gilead's international sites or global trials that seek regional approvals.
• Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation for clinical trials conducted at Gilead's international sites or global trials that seek regional approvals.
• Manage a team of diversified statistical programmers to support analyses and regulatory submissions of clinical trials conducted at Gilead's international sites or global trials that seek regional approvals.
• 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) for Oncology studies.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Has a thorough understanding of Oncology clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions, especially with FDA, NMPA, and PMDA.
• Has hands-on and leading experience with regulatory submissions to global agencies including but not limited to PMDA, NMPA, FDA, EMA, and post-filing activities.
• Experience with and demonstrated ability to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
• Has the proven ability to anticipate and resolve study related issues and conflicts within a therapeutic project.
• Experience with and proven ability in oversight or managing outsourced studies.
• Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines.
• Manages critical deadlines, demonstrates ability to resolves issues, and ensures studies will be completed within designated timeframe.
• Viewed as a key resource by more senior individuals on technical initiatives and may represent the Company on contracts.
• Identifies and leads strategic initiatives for the programming group.
• Serves as project lead on studies of greater complexity.
• Experience with attending CST (Clinical Sub- Team) meetings as a representative of Programming group.

Typical Education and Experience:

• 9 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.
• 3 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.