Manager, Statistical Programming Oncology
United States - Washington - SeattleUnited States – RemoteUnited States - New Jersey - Morris PlainsUnited States - California - Foster City
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 #CreatingPossibleFor Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job DescriptionManager, Statistical Programming - OncologyKey Skills:
- Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
- Generates or oversees the production of statistical output (e.g., tables, figures, listings) for study reports and integrated summaries.
- Actively share experience and discuss possible process enhancements
- 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 Oncology late phase (phase II, III) and early phase (e.g., Dose Escalation) studies.
- Has experiences with Oncology electronic data package generation including define 2.0 and reviewer's guide.
- Has in-depth knowledge with efficacy validation for response and efficacy analyses for Oncology studies.
Education and Experience:
- Works collaboratively with Biostatistician and Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
- Generates or oversees the production/validation 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 an Oncology 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 an Oncology project.
- Can create buy-in and support and has the ability to negotiate timelines.
For Colorado Job Applicants:
- 6 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.
The salary range for this position is:
$115,600.00 - $173,400.00
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 https://www.gilead.com/careers/compensation-benefits-and-wellbeing
For jobs in the United States:
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 firstname.lastname@example.org
for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'Know Your Rights'
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.