Director, Biostatistics

Gilead Sciences, Inc. • Foster City, CA

59d

About The Position

The Biostatistics function at Gilead works 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 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 late-stage development, working collaboratively for the development plans, regulatory interactions, and HTA/commercial evaluation of a Gilead Oncology compound in one or more indications.

Requirements

• 12 years + (Bachelors); 10+ years (Masters); 8+ 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 oncology drug development including design and analysis of phase 3 oncology 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

Responsibilities

• Provide Statistical leadership to late-stage 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 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees