Sr. Manager, Biostatistics - Virology

Descripción del trabajo

Senior Manager, Biostatistics – Virology

United States – California – Foster City

Biostatisticians work collaboratively with internal and external colleagues to ensure appropriate design, statistical analysis and reporting of Gilead clinical data in efficiently achieving regulatory, scientific and business objectives. Primarily responsible for the business, operational, and compliance aspects of drug discovery, development, and marketed products at Gilead.

Key Skills

• Leads the statistical analysis, document review, and data interpretation for inclusion in NDA submissions.
• Oversees and contributes to the completion of all technical and operational statistical activities for a group of clinical trials.
• Is a point of influence in setting strategy for the group.
• Defends results and analysis externally.

Job Responsibilities

• Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking.
• Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources.
• Provides senior level review of various technical documents.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Offers advice to others within the company to help make better decisions and resolve problems.
• Ability to examine issues from various perspectives and apply appropriate concepts to address situations.
• Must be able to determine the functions most critical to company success and to support priorities within functional area.
• Addresses obstacles and difficulties of internal and external teams across multifunctional project or functional areas in order to meet goals.
• Can pull together highly effective teams and create a clear sense of direction.

Education and Experience

• PhD and at least 2+ years of industry experience preferred.
• 8 years of industry experience in the statistical analysis of biomedical data using SAS® software and a BS degree in Biostatistics or equivalent.
• 6 years of industry experience in the statistical analysis of biomedical data using SAS® software and MS degree in Biostatistics or equivalent