Biostatistics Oncology TA Head

Career Category

Clinical

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistics Oncology Therapeutic Area Head

What you will do

Let’s do this. Let’s change the world. In this vital role as, Biostatistics Oncology TA Head, you will define enterprise-level strategy for the function.

This role sets vision, represents Biostatistics for Oncology at the highest levels of the organization, and acts as the external face of the function to regulators, industry groups, and scientific forums. In this role you will be operating with significant autonomy, and drive innovation, talent development, and organizational transformation.

Responsibilities:

• Sets and leads the biostatistical strategy and technical expertise for Oncology TA, including opportunities for innovation and continuous improvement
• Advises and collaborates with cross-functional TA Heads, including related analytical groups, across Amgen regarding statistical strategies that impact drug development and regulatory/HTA/medical strategies
• Identifies and implements new pragmatic methodologies aimed at improving drug development strategy, regulatory science, and patient centricity
• Provide statistical consultancy, training, and advice within Amgen
• Drive and contribute to the development of Amgen Policies, SOPs and other controlled biostatistics documents
• Implement and manage standards, technical quality, and consistent approaches in strategy, study design, and statistical analysis for designated TAs
• Influence Amgen’s statistical priorities internally and externally via KOL relationships, publications, presentations, and through key partnerships as appropriate
• Provide oversight for Key Design Elements (KDE), protocols, Statistical Analysis Plans (SAPs), Flash Memos/Summary of Report (SoR), Clinical Study Reports (CSRs), publications, and contribute to regulatory documents in various development stages, reimbursement documents and other communications for TAs
• Partners with functional leaders across Amgen and with external stakeholders
• Contributes to CfDA organizational strategy as part of leadership team; serves as a primary representative for Oncology TA at Amgen-wide committees and meetings
• Engages and aligns staff with Amgen priorities, including identifying and championing impactful and innovative opportunities for Oncology TA
• Leads decisions regarding statistical differences of opinion (e.g., statistical methodologies) within Oncology TA
• Manages technical and good practice oversight within Oncology TA
• Provide statistical strategy on signal detection capabilities for use in the analysis of pre-marketing and post-marketing adverse event databases, and on life-cycle safety-related activities for a product

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

The executive candidatewe are looking for is an experienced leader with the following qualifications.

Basic Qualifications:

• Doctorate degree & 6 years of biostats oncology experience OR
• Master’s degree & 10 years of biostats oncology experience OR
• Bachelor’s degree & 12 years of biostats oncology experience AND
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Experience developing policies and SOPs
• International collaboration and experience working globally
• Scientific research / publications in one or more areas of statistical science
• Experience working effectively in a globally dispersed team environment with cross-cultural partners
• Life Cycle Drug Development Experience (e.g. global product lead statistician experiences)
• Excellent oral and written English communication skills
• Thorough understanding of regulatory and industry trends in standards and their implementation
• Established records of strong leadership and people management skills
• Prior regulatory and reimbursement submission experience, including advisory committees

…