Job Description
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
Sr Manager, Statistical Programming
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 projects and may represent the Company on contracts.
- Inform functional management programming resources required for the project.
- Has experiences in leading 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 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 study reports and integrated summaries.
- Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within an 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 a project or equivalent.
- Is responsible for implementing efficacy validation, efficacy analysis datasets and TFLs for studies.
- Provides primary and secondary programming support as needed for 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.
- 2 years of experience and a PhD degree in Biostatistics / Computer Sciences or equivalent.
The salary range for this position is : $165,580.00 - $214,280.00. 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*.