[Hiring] Senior Director, Biostatistics @Amgen

Role 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.

In this vital role you will:

• Provide strategic statistical input to and oversee all statistical aspects of biosimilar development for all products.
• Lead, manage, and develop the team of biosimilars biostatisticians.
• Oversee the performance of biostatisticians in Contract Research Organizations (CROs).
• Enhance statistical understanding within Biosimilar Development.
• Develop innovative methodologies and study designs for biosimilars.
• Assist the head of Biostatistics and Statistical Programming in leading the department.

Responsibilities include:

• Provide oversight for protocols, Statistical Analysis Plans, Flash Memos/Summary of Report, Clinical Study Reports, submission documents, correspondences with health authorities, clinical publications, reimbursement documents, and other communications.
• Develop and maintain successful application of statistical excellence in design, analysis, and reporting to all phases of biosimilar development.
• Ensure standards, technical quality, and consistent approaches in clinical development strategy, study design, and statistical analysis.
• Ensure excellent statistical input into regulatory strategies, presentations, and scientific reports for clinical trials.
• Represent Biosimilar Development on statistical matters at meetings with regulatory authorities and key opinion leaders.
• Provide oversight and guidance to staff members within Amgen and in CROs in completing study deliverables according to agreed timelines.
• Responsible for hiring, allocation, management, and development of internal statistical staff.
• Lead and/or participate in the development and review of Policies, SOPs, and other controlled documents.
• Promote, communicate, and become an expert in specific statistical methodologies.
• Develop and maintain long-term relationships with key statistical opinion leaders, including academics and regulators.

Qualifications

• Doctorate degree and 5 years of Senior Director, Biostatistics experience OR
• Master’s degree and 9 years of Senior Director, Biostatistics experience OR
• Bachelor’s degree and 11 years of Senior Director, Biostatistics experience.
• At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Requirements

• Established records of strong leadership and people management skills.
• Statistical leadership to regulatory submissions, including advisory committees.
• Demonstrated effective communication skills including statistical strategy (written and oral).
• Doctorate in Statistics/Biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR
• Master’s degree in Statistics/Biostatistics and at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
• Ten years of post-graduate statistical experience in the pharmaceutical industry.
• Demonstrated ability to work within a global team and with CRO partners to ensure operational excellence and efficiencies.
• Life cycle Drug development experience (Pre-clinical Development, Clinical Development, and Post-marketing).
• Knowledge/experience of Biosimilars development, including global regulatory requirements and design and analysis of non-inferiority and equivalence trials.

Benefits

• Salary Range: 223,624.80 USD - 302,551.20 USD