Associate Director, Statistical Programming

Associate Director, Statistical Programming

Locations: United States - Washington - Seattle

Time Type: Full time

Posted on: Posted 5 Days Ago

Job Requisition ID: R0042479

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.

Job Responsibilities and Skills:

1. Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
2. Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.
3. Anticipates resource needs and works with management and HR to ensure adequate long-term resource allocation within a therapeutic project.
4. Manages a team of diversified statistical programmers.
5. Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
6. Directs the design and/or coding of analysis files.
7. Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent.
8. Excellent verbal and written communication skills and interpersonal skills are required.
9. Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions with FDA, PMDA, and other global agencies.
10. Experience with regulatory submissions and post-filing activities such as FDA, EMA, PMDA filing, RtQs, and inspections.
11. Experience with and demonstrated ability to interact with other departments to define and produce user-defined statistical reports (e.g., ad hoc requests).
12. Has the proven ability to anticipate and resolve study-related issues and conflicts within a therapeutic project.
13. Experience with and proven ability in oversight or managing outsourced studies.
14. Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines.
15. Manages critical deadlines, demonstrates ability to resolve issues, and ensures studies will be completed within designated timeframe.
16. Responsible for all statistical programming activities within a therapeutic project or equivalent.
17. Identifies and leads strategic initiatives for the programming group.
18. Serves as project leader on studies of greater complexity.

Typical Education and Experience:

1. 10 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.
2. 8 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.
3. 2 years of experience and a PhD degree in Biostatistics/Computer Science or equivalent.

The salary range for this position is: $173,910.00 - $225,060.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics.