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About the Role

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.

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, figures, listings) for study reports and integrated summaries.
• Anticipates resource needs.
• Directs the design and/or coding of analysis files.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Provides primary and secondary programming support as needed.
• Implements strategic initiatives.
• Must be able to interact with other departments 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 can negotiate timelines.

Requirements

• Excellent verbal and written communication skills and interpersonal skills are required.
• Solid analytical skills with advanced knowledge of statistics.
• Proven track record on multiple, time-sensitive, and complex tasks.
• Has a thorough understanding of clinical trials design and reporting processes, as well as regulatory reporting requirements including electronic data submissions for multiple therapeutic areas, especially with FDA, PMDA, EMA, and other global agencies.
• Experience with integrated analysis activities for FDA and rest of world submissions plus their post-filing activities.

Skills

• SAS software
• SAS Macros
• CDISC standards (CDASH, SDTM, ADaM)
• CDISC standards
• CDASH
• SDTM
• ADaM
• GCP
• ICH

Location

• Foster City, CA
• Raleigh, NC

Work Type

• HYBRID

Experience Level

• 8+ years’ experience in pharma/biotech (BS degree)
• 4+ years’ experience in pharma/biotech (MS degree)
• 2+ years of experience in pharma/biotech (PhD degree)
• 8+ years of pharmaceutical/CRO experience
• Prior experience in oncology, hematology, virology, and Inflammation is strongly preferred.
• Hands-on experience in pivotal studies and regulatory submissions (NDA, BLA, MAA, etc.)
• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros
• Proven experience in complex and fast turnaround programming activities

Education Level

• BS degree in Biostatistics/Computer Science or equivalent
• MS degree in Biostatistics/Computer Science or equivalent
• PhD degree in Biostatistics/Computer Sciences or equivalent

Salary/Compensations

• Bay Area: $169,320.00 - $219,120.00
• Raleigh: $146,200.00 - $189,200.00

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

About the Company

• Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
• The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
• Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Equal Opportunity

• Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.
• Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.
• For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
• NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
• YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
• Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
• However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
• Our environment respects individual differences and recognizes each employee as an integral member of our company.
• Our workforce reflects these values and celebrates the individuals who make up our growing team.
• Gilead provides a work environment free of harassment and prohibited conduct.
• We promote and support individual differences and diversity of thoughts and opinion.