Senior Manager, Statistical Programming (Virology) Location: Foster City, CA - 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, figures, listings) for study reports and integrated summaries. - Anticipates resource needs and works with management and HR to ensure adequate long-term resource... more details
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Job Description
Senior Manager, Statistical Programming (Virology)
Location: Foster City, CA
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, figures, listings) for study reports and integrated summaries.
* Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a Virology therapeutic area project.
* May manage a small team of statistical programmers.
* 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.
Oversees and is responsible for all pediatric programming activities within a
* Virology therapeutic area project or equivalent.
* Provides primary and secondary programming support as needed.
Implements strategic initiatives.
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* 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 for the Virology therapeutic area pediatric projects, especially with FDA, EMEA, and other global agencies.
* Experience with leading FDA NDA submissions and post-filing activities.
* Must be able to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
* 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.
* Has the ability to directly supervise personnel.
* Manages critical deadlines, demonstrates ability to resolves issues, and ensures studies will be completed within designated timeframe.
* Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
* Viewed as a key resource by more senior individuals on technical initiatives and may represent the Company on contracts.
* Inform functional management programming resources required for the projects.
* Recommends and provides trainings.
* Serves as project leader.
* Participates in cross-functional meetings as a representative of Programming group.
Typical Education and Experience:
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.
The salary range for this position is: $165,580.00 - $214,280.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
