Associate Director, Biostatistics

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Job Description
 

Associate Director, Biostatistics

Position Overview:

Biostatisticians at Gilead 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. The Associate Director will be primarily responsible for the business, operational, and compliance aspects of Oncology drug discovery, development, and marketed products at Gilead. He/she will support oncology clinical development, working collaboratively for the development plans, regulatory interactions, and HTA/commercial evaluation of a Gilead Oncology compound in one or more indications.

Key Responsibilities:

• Provide Statistical leadership to oncology clinical trials: developing trial design options and providing high quality decision support
• Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to Biostatistics function TA leaders
• Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management colleagues 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, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance
• 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
• Leads one or more components of departmental strategic initiatives

Education & Experience

• 10 years + (Bachelors); 8+ years (Masters); 6+ years (PhD): 0+ years (MD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
• Industry experience in the statistical analysis of biomedical data using statistical software
  Extensive hands-on experience in oncology drug development including design and analysis of oncology trials and active participation in regulatory interaction
• Demonstrated effective verbal and written communication skills and interpersonal skills are requir