Associate Director, Statistical Programming
Associate Director, Statistical Programming
Ireland - Dublin
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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 therapeutic project.
- Initiates contracts and oversees work utilizing external resources.
- Manage a team of statistical programmers and/or contractors.
- 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 the Virology therapeutic area projects or equivalent.
- Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across the Virology therapeutic area or equivalent pediatric 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 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.
- 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.
- Proven ability to create buy-in and support and has demonstrated 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.
- 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 leader on studies of greater complexity.
- Experience with attending CST (Clinical Sub-Team) meetings as a representative of Programming group
Typical Education and Experience:
- Significant years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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