Gilead Sciences Inc

Senior Manager, Statistical Programming

Gilead Sciences Inc$146K — $189K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • BS/MS/PhD in Biostatistics or Computer Science
  • 8+ years (BS) or 4+ years (MS) or 2+ years (PhD) of experience in pharma/biotech
  • Strong knowledge of clinical trials design and regulatory reporting
  • Extensive experience in statistical programming with SAS, including macros
  • Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM)

Responsibilities

  • Collaborate with Clinical Development to meet statistical data analysis deliverables and timelines
  • Generate and oversee programming deliverables for study reports
  • Anticipate resource needs for statistical programming
  • Direct the design and coding of analysis files
  • Ensure programming adheres to departmental procedures
  • Provide primary and secondary programming support as needed
  • Implement strategic initiatives

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans
  • Discretionary annual bonus eligibility
  • Discretionary stock-based long-term incentives (role-dependent)
  • Paid time off
Full Job Description
Job Description

We are in search of a Sr Manager, Statistical Programming to join our team! Statistical Programming- Analysis Programming: 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.

This is a HYBRID position at our Foster City, CA OR Raleigh, NC locations. This is NOT a fully remote position.

Key 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.
  • 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.
  • 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.


Basic Qualifications:
  • BS degree in Biostatistics/Computer Science or equivalent and 8+ years' experience in pharma/biotech -OR -
  • MS degree in Biostatistics/Computer Science or equivalent and 4+ years' experience in pharma/biotech -OR -
  • PhD degree in Biostatistics/Computer Sciences or equivalent 2+ years of experience in pharma/biotech


Preferred Qualifications:
  • Degree in Biostatistics/Computer Science or equivalent
  • 8+ years of pharmaceutical/CRO experience
  • Prior experience in oncology, hematology, virology, and Inflammation is strongly preferred.
  • Knowledge of submission knowledge strongly preferred
  • Hands-on experience in pivotal studies and regulatory submissions (NDA, BLA, MAA, etc.)
  • In-depth understanding of clinical programming and/or statistical programming processes and standards
  • In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
  • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros
  • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
  • Proven experience in complex and fast turnaround programming activities
  • Excellent interpersonal, communication, problem solving, and analytical skills


The salary range for this position is:
Bay Area: $169,320.00 - $219,120.00.

Raleigh: $146,200.00 - $189,200.00.

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

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Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

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At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

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Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

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Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

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Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ

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