Senior Manager, Statistical Programming Lead
4 weeks ago
We are seeking a highly skilled Senior Manager, Statistical Programming Lead to join our Clinical Development team at Gilead Sciences. As a key member of our team, you will be responsible for leading the development of statistical programming deliverables, collaborating with clinical development staff to meet project timelines, and ensuring the quality of our data analysis and reporting.
Key Responsibilities- Lead the development of statistical programming deliverables, including tables, figures, and listings, for study reports and integrated summaries.
- Collaborate with clinical development staff to meet project timelines and ensure the quality of our data analysis and reporting.
- Anticipate resource needs and work with management and HR to ensure adequate long-term resource allocation within a project.
- May manage a small team of statistical programmers.
- Direct the design and/or coding of analysis files.
- Ensure programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
- Provide primary and secondary programming support as needed.
- Implement strategic initiatives.
- 8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
- 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
- 2 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.
- Excellent verbal and written communication skills and interpersonal skills.
- Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions for the Virology therapeutic area, especially with FDA, EMEA, and other global agencies.
- Viral Hepatitis, especially HBV and HDV experience preferred.
- Experience with leading 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.
- Ability to create buy-in and support and negotiate timelines.
- Ability to directly supervise personnel.
- Competitive salary range: $165,000 - $214,000.
- Discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
- Company-sponsored medical, dental, vision, and life insurance plans.
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