This position may be located at Amgen's headquarters in Thousand Oaks, California, or may be field-based as a remote position.
The Biostatistics Senior Manager is responsible for contributing to the design, conduct, and analysis of studies and supporting the development of Amgen oncology products.
In this role, the Biostatistics Senior Manager will:
• Serve as a Study Lead Statistician and/or an indication lead statistician for an Amgen oncology product
• Create statistical text for study protocols, reports, clinical publications and other communications
• Represent Biostatistics in meetings with regulatory agencies and prepare oral/written responses to agency questions, as needed
• Promote understanding of statistical methods with particular applicability to oncology
• Stay abreast of latest developments in the field of statistics with an emphasis on group sequential, adaptive, and Bayesian designs
• Maintain close working relationships with cross-functional team members
• Oversee the creation of statistical analysis plans; templates for tables, listings, and graphs; and data set specifications.
• Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings
• Contribute to continuous process development of Global Biostatistical Science
• Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 2 years of clinical statistical experience
• Master's degree in Statistics/Biostatistics or other subject with high statistical content, and 6 years of clinical statistical experience
• Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Master's degree in Statistics/Biostatistics or other subject with high statistical content, and 8+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Solid understanding of theoretical and applied statistics, especially in the areas of categorical data analysis, survival analysis, and Bayesian statistics
• Solid understanding of regulatory guidelines (FDA, EMA) in clinical study design, analysis, and reporting
• 4+ years as a statistician in a pharmaceutical or biotech industry with clinical trial/regulatory interaction (including NDA filing) experience, especially in oncology area
• Fluency in R and/or SAS
• Good written and verbal communication skills
• Solid analytical/problem solving skills
• Direct report management experience and project/process management experience preferred
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.