Associate Director, Biostatistics

职位描述

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 Virology drug discovery, development, and marketed products at Gilead. He/she will support Virology drug development, working collaboratively for the development plans, regulatory interactions, and commercial evaluation of a Gilead Virology compound in one or more indications.

Key Responsibilities:

• Provide Statistical leadership to Virology clinical trials: developing trial design options and providing high quality decision support.

• Statistical lead for a specific Virology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head

• 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, 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 two or more components of departmental strategic initiatives

Education & Experience

• 10 years + (Bachelors); 8+ years (Masters); 6+ years (PhD) 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 drug development including design and analysis of phase 1-3 trials and active participation in NDA/BLA filing through label negotiation

• Demonstrated effective verbal and written communication skills and interpersonal skills are required

• Examines functional issues from a broader organization perspective

• Proven ability to determine the functions most critical to company success and to support priorities within functional area

• Anticipates obstacles and difficulties of clients and acts to meet goals

• Proven ability to pull together and lead highly effective teams and create a clear sense of direction

• Proven ability to design and use all available vehicles for effective scientific communication within and outside the company