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Associate Director, Statistical Programming (Oncology)

Gilead Sciences, Inc.

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Morris Plains, NJ
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Job Description

As posted by the hiring company

Job Overview:

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Associate Director, Statistical Programming (Oncology)

*This position is located in Morris Plains, NJ.

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, listings) for study reports and integrated summaries within Genitourinary (GU) disease area.

- Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation for studies within the GU disease area.

- Manage a team of diversified statistical programmers to support analyses and regulatory submissions of studies within the GU disease area.

- 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.

- Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across the GU disease area.

- Excellent verbal and written communication skills and interpersonal skills are required.

- Thorough understanding of Oncology clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions, especially with FDA and EMA

- Experience with leading FDA NDA/sNDA/BLA/sBLA 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).

- Proven ability to anticipate and resolve study related issues and conflicts within a therapeutic project.

- Experience with and proven ability in oversight or managing outsourced studies.

- Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines.

- 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

Education and Experience:

- 10 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.

- 8 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.


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 careers@gilead.com 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, and Singapore 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.​

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.


For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.