Job Details

Senior Manager, Statistical Programming - Oncology
United States - California - Foster CityUnited States - RemoteUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle

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. Gilead's 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 company's five core values. That's 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

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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.Job Description

Sr Manager, Statistical Programming (Oncology)

The position is site-based.

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 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 for Oncology projects and may represent the Company on contracts.
• Inform functional management programming resources required for the project.
• Has experiences in leading Oncology studies and deep understanding of end-to-end data standards (e.g., collection, mapping, analysis, reporting and submission).
• Has experiences with both late phase (phase II, III) and early phase (e.g., Dose Escalation) studies.
• Has in-depth knowledge with efficacy validation and efficacy analyses for Oncology studies.
• Has experience with regulatory submissions including but limited to PMDA, NMPA, FDA, EMA, and post-filling activities.
• Recommends and provides trainings.

Job responsibilities:

• Works collaboratively with Biostatistics and Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting for clinical trials conducted at Gilead's international sites or global trials that seek regional approvals.
• Generates or oversees the production of programming deliverables (e.g., tables, listings) for Oncology 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 within an Oncology project.
• May manage a small team of programmers.
• Designs and/or codes analysis files.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Is responsible for all programming activities within an Oncology project or equivalent.
• Is responsible for implementing efficacy validation, efficacy analysis datasets and TFLs for Oncology studies.
• Provides primary and secondary programming support as needed for Oncology projects.
• Implements strategic initiatives.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Has a thorough understanding of clinical trials design and reporting process.
• Must be able to interact with others 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.

Education and Experience:

• 8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
• 6 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.

For Colorado Job Applicants: The salary range for this position is:
$137,600.00 - $206,400.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit [ Link removed ] - Click here to apply to Senior Manager, Statistical Programming - Oncology
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [ Email address blocked ] - Click here to apply to Senior Manager, Statistical Programming - Oncology for assistance.

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