Hiring company: Gilead
Manager, Statistical 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.
Key Skills
- Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis.
- Generates or oversees the production of statistical output (e.g., tables, listings) for study reports and integrated summaries.
- Actively share experience and discuss possible process enhancements at programming meetings.
- Recommends potential trainings.
- 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.
- Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
- Is responsible for all programming activities within a therapeutic project or equivalent.
- Implements strategic initiatives.
- Must be able to lead and manage multiple concurrent projects.
- 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.
- Has the ability to resolve study related issues and conflicts within a therapeutic project.
- Can create buy-in and support and has the ability to negotiate timelines.
Education and Experience
- 7 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.
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