Biostatistics Oncology TA Head

Amgen•Thousand Oaks, CA

8d•$267,393 - $361,767

About The Position

Amgen is seeking a Biostatistics Oncology Therapeutic Area Head to define enterprise-level strategy for the function. The role sets the vision, represents Biostatistics for Oncology at senior organizational levels, and serves as the function’s external representative to regulators, industry groups, and scientific forums. It operates with significant autonomy and drives innovation, talent development, and organizational transformation. The position leads biostatistical strategy and technical expertise for the Oncology therapeutic area, advises cross-functional leaders on statistical strategies affecting drug development and regulatory, health technology assessment, and medical strategies, and provides statistical consultancy and training within Amgen. It also oversees statistical standards and quality across strategy, study design, and analysis; contributes to company policies and controlled documents; and represents Oncology in company-wide committees and meetings. The role provides oversight for key design elements, protocols, statistical analysis plans, study summaries and reports, publications, and contributions to regulatory and reimbursement documents. It partners with internal functional leaders and external stakeholders, influences statistical priorities through professional relationships and scientific communication, leads resolution of statistical differences of opinion within Oncology, and provides strategy for safety signal detection and lifecycle safety activities.

Requirements

Doctorate degree and 6 years of biostatistics oncology experience, or master’s degree and 10 years, or bachelor’s degree and 12 years.
At least 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
Excellent oral and written English communication skills.
Thorough understanding of regulatory and industry trends in standards and their implementation.
Established record of strong leadership and people-management skills.
For the stated preferred experience profile: doctorate in Statistics/Biostatistics or a related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research, including related Oncology therapeutic area experience; or a master’s degree in Statistics/Biostatistics or a related subject with high statistical content and at least 16 years of such post-graduate statistical experience.

Nice To Haves

Experience developing policies and SOPs.
International collaboration and experience working globally.
Scientific research or publications in one or more areas of statistical science.
Experience working effectively in globally dispersed teams with cross-cultural partners.
Lifecycle drug development experience, such as global product lead statistician experience.
Prior regulatory and reimbursement submission experience, including advisory committees.
Doctorate in Statistics/Biostatistics or a related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research, including related Oncology therapeutic area experience; alternatively, a master’s degree in Statistics/Biostatistics or a related subject with high statistical content and at least 16 years of such experience.

Responsibilities

Set and lead biostatistical strategy and technical expertise for the Oncology therapeutic area, including innovation and continuous improvement.
Advise and collaborate with cross-functional therapeutic area heads and related analytical groups on statistical strategies that affect drug development and regulatory, HTA, and medical strategies.
Identify and implement pragmatic methodologies to improve drug development strategy, regulatory science, and patient centricity.
Provide statistical consultancy, training, and advice within Amgen.
Drive and contribute to development of Amgen policies, SOPs, and other controlled biostatistics documents.
Implement and manage standards, technical quality, and consistent approaches to strategy, study design, and statistical analysis for designated therapeutic areas.
Influence Amgen’s statistical priorities internally and externally through KOL relationships, publications, presentations, and partnerships.
Oversee Key Design Elements, protocols, Statistical Analysis Plans, Flash Memos/Summaries of Report, Clinical Study Reports, publications, and contributions to regulatory documents, reimbursement documents, and other communications.
Partner with Amgen functional leaders and external stakeholders.
Contribute to CfDA organizational strategy as a leadership team member and serve as a primary representative for Oncology at Amgen-wide committees and meetings.
Engage and align staff with Amgen priorities and identify and champion impactful, innovative opportunities for Oncology.
Lead decisions about statistical differences of opinion within Oncology, such as disagreements about statistical methodologies.
Manage technical and good-practice oversight within Oncology.
Provide statistical strategy for signal detection in pre-marketing and post-marketing adverse-event database analyses and for product lifecycle safety activities.