Manager, Statistical Programming

About Gilead

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

Serves as a project lead to provide oversight on multiple outsourced aggregated product level safety analyses projects. Acts as a fluent programmer in sophisticated Clinical Safety Surveillance analyses projects. Independently identifies issues in the analysis and assures project quality consistency. Acts as a stakeholder in multi-functional discussion on project scope, milestone, and project timeline negotiation.

Project Involvement

• Acts as lead programmer for multiple projects.
• May serves as project leader.
• Overseeing vendor project activities and deliverables

Key Differentiating Contribution

• Generates or oversees the production of statistical output (e.g., tables, listings) for aggregated compound level safety projects.
• Actively share experiences and discuss possible process enhancements at programming meetings.
• Recommends potential trainings.
• Independently identifies issues in the analysis from previous experience and knowledge.
• Provides consistency and quality assurance across various studies.

Promotional Criteria

A promotion from this position may be recognition for sustained performance and high potential. Demonstrates strong project management skills including ability to anticipate time, resources and staffing required to successfully complete multiple projects.

Training and Development Opportunity

Attend a conference or class related to SAS, eCTD, CDISC, project management training.

Job Responsibility 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 safety analysis reports and to support process improvement initiatives.
• Exhibits strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Must be able to lead and manage multiple concurrent projects.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Has a thorough understanding of clinical trials design and reporting process.
• Knowledge of clinical safety (DSUR/PSUR, IB RSI, RMP, CSS) reporting requirements is a plus.
• Has the ability to resolve study related issues and conflicts within a therapeutic project.
• Can create buy-in and has the ability to negotiate timelines.
• Uses internal macros or writes SAS® macros to automate deliverables.
• Responsible for harmonizing source data across multiple studies, creation and validation of Analysis Datasets and TLFs for all safety deliverables following department standards.
• Analyze vendor performance through assessment of Key Performance Indicators.