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Title:Director, Biostatistics
Salary:Open
Experience:3+
Location:CA - South San Francisco

Description:
This position will lead Biostatistic groups in support of clinical development for multiple oncology/hematology biotherapeutics.

Responsibilities:

·         Line management responsibility for Biostatistics managers and project Biostatisticians, including coaching, training, setting employee goals, doing performance reviews, and managing resources and budget

·         Sets goals, priorities, vision, and direction for the function

·         Accountable for the statistical input provided by the group to all major documents, including clinical development plans, protocols, analysis plans, clinical study reports, summaries of clinical safety and efficacy, and other sections of BLAs

·         Senior advisor to Biostatisticians and managers on drug development strategies and issues associated with clinical trial design, conduct, analysis, and reporting

·          Guides Biostatisticians and managers in FDA interactions, including FDA meetings, responses to FDA questions, and Advisory Committee Meetings

·         Builds strong relationships with Clinical Science, Health Outcomes and Outcomes Research, Clinical Operations, Regulatory, and Commercial management in order to effectively define strategic approaches to drug development and clinical trials and to meet operational requirements of development plans

·          Partners with other Biostatistics Directors to ensure a coordinated and efficient approach to Biostatistics responsibilities

·         Maintains comprehensive knowledge of theoretical and applied statistics and regulatory guidelines regarding drug development strategies and clinical trial design, analysis, and reporting.

·         Supports the application of new methodologies to Genentech projects as appropriate

·         Reports to Senior Director, Biostatistics and Epidemiology

Requirements:

·          Ph. D. in statistics/biostatistics with at least 8 years of drug
development experience, preferably with oncology drug development experience.

·         At least 3 years experience managing statisticians.

·         Comprehensive understanding of theoretical and applied statistics.

·         Comprehensive understanding of regulatory guidelines in a pharmaceutical research setting.

·         BLA/NDA development and submission experience required.

·         Ability to effectively collaborate, with broad knowledge and perspective.

·         Strong leadership abilities. Able to communicate, motivate, and influence throughout all levels of the organization.

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