Gilead Sciences, Inc.
Associate Director, Biostatistics - Virology
Gilead Sciences, Inc., Foster City, California, United States, 94420
Associate Director, Biostatistics - Virology
Location: This position can be based in Foster City, CA or Seattle, WAPosition 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 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.The salary range for this position is: $191,335.00 - $247,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.For additional benefits information, visit:
Gilead Benefits .As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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Location: This position can be based in Foster City, CA or Seattle, WAPosition 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 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.The salary range for this position is: $191,335.00 - $247,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.For additional benefits information, visit:
Gilead Benefits .As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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