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Gilead Sciences, Inc. Senior Manager, Statistical Programming - Oncology in Morris Plains, New Jersey

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.

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Job Description

Sr Manager, Statistical Programming (Oncology)

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.

  • Recommends and provides trainings.

Job responsibilities:

  • 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 Oncology study reports and integrated summaries.

  • 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, as well as regulatory reporting requirements including electronic data submissions.

  • 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.

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

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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 careers@gilead.com for assistance.

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