Biostatistics Oncology TA Head
About The Position
The Biostatistics Oncology Therapeutic Area Head defines enterprise-level strategy for the Biostatistics function in Oncology. The role sets the vision, represents Oncology Biostatistics at senior organizational levels, and serves as an external representative to regulators, industry groups, and scientific forums. With significant autonomy, the role drives innovation, talent development, and organizational transformation. The position leads statistical strategy and technical expertise across the Oncology therapeutic area, provides strategic guidance for drug development and regulatory, health technology assessment, medical, reimbursement, and safety activities, and maintains technical quality and consistent statistical practices. It oversees key study and reporting materials and contributes to organizational strategy, policies, standards, and cross-functional partnerships. The role requires an experienced leader with substantial oncology biostatistics and people or team leadership experience. Amgen describes a collaborative, science-based culture and offers a Total Rewards Plan, subject to eligibility. The expected U.S. annual salary range, excluding Puerto Rico, is $267,393–$361,767; actual pay depends on relevant skills, experience, and qualifications.
Requirements
- Doctorate degree and 6 years of biostatistics oncology experience, or a master’s degree and 10 years, or a 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.
Nice To Haves
- Experience developing policies and SOPs.
- International collaboration and global work experience.
- Scientific research or publications in one or more areas of statistical science.
- Experience working effectively in globally dispersed teams with cross-cultural partners.
- Life-cycle drug development experience, such as global product lead statistician experience.
- Excellent oral and written English communication skills.
- Thorough understanding of regulatory and industry trends in standards and their implementation.
- Strong leadership and people-management record.
- 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; or a master’s degree in such a subject and at least 16 years of corresponding post-graduate statistical 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 affecting 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 developing 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 key opinion leader 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 therapeutic-area communications.
- Partner with functional leaders across Amgen and with external stakeholders.
- Contribute to CfDA organizational strategy as a leadership team member and represent Oncology at Amgen-wide committees and meetings.
- Engage and align staff with Amgen priorities, identifying and championing impactful and innovative opportunities for Oncology.
- Lead decisions on statistical differences of opinion, including statistical methodologies, within Oncology.
- Manage technical and good-practice oversight within Oncology.
- Provide statistical strategy for signal detection in pre- and post-marketing adverse-event databases and for product life-cycle safety activities.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Retirement and Savings Plan with company contributions.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans and bi-annual company-wide shutdowns.
- Flexible work models where possible.
- Career development opportunities.
- Work/life balance support.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
