Senior Manager, Statistical Programming

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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…