Biostatistics Associate Director

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Assoc Dir Biostatistics for Exploratory Analysis

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What you will do

Accountabilities

• Provide support for Precision Medicine
• Implement key projects, deliverables and operational tasks related to exploratory biostatistical strategy, technical expertise, and reporting within designated studies / products
• Execute statistics strategy, implement standards and approaches to ensure quality and technical excellence in strategy, exploratory analysis planning, and statistical analyses
• Advise and lead statisticians on and techniques for analysis to align with industry standards and to provide valid, robust conclusions
• Opportunity to serve as the product or disease area exploratory analysis lead, as needed

Responsibilities

• Provide dedicated support for Precision Medicine
• Apply knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, clinical trial biomarker (CTA) and companion diagnostics (CDx) co-development, and precision Medicine organization.
• Plan and implement statistical activities contributing to exploratory statistical analysis plans, reports and publications
• Implement, lead and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
• Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
• Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
• Oversee statistical contributions to statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
• Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
• Serve as the EBG lead on the Evidence Generation Team (EGT) or Clinical Study Team (CST) with exploratory analysis needs to support Precision Medicine or drug/CDx co-development
• Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
• Provide statistical consultancy, training, and advice within Amgen
• Participate in process improvement initiatives and operational efficiencies
• Oversee FSP statisticians and check their contributions for quality
• Chance to lead staff, e.g. external contractors
• Opportunity to serve as a product or disease area exploratory analysis biostatistical lead to support Precision Medicine

Qualifications

• Life Cycle Drug Development Experience
• Independent leadership on project(s)
• Experience working in a globally dispersed team environment with cross-cultural partners
• Strong oral and written communication in English

Basic Qualifications

• Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Preferred Qualifications

• At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
• Life Cycle Diagnostic Development Experience (Pre-clinical & Clinical), clinical trial biomarker (CTA) and companion diagnostic (CDx) co-development experience strongly preferred
• Regulatory interaction experience with global regulators in drug and diagnostic device (e.g., CDER and CDRH)
• Statistical leadership and contribution to regulatory submissions and publications
• Statistical expertise in exploratory biomarker analysis
• Thorough understanding of regulatory and industry guidelines, trends and good practices

Competencies

Scientific / Technical Leader