Lead and manage biostatistical programming activities for Amgen’s Biosimilar organization, coordinating with CROs and cross‑functional teams to develop datasets, analysis plans, and submission packages.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 151,838.05USD -205,427.95 USD
Responsibilities
Represent the product programming function and participate in multidisciplinary project team meetings
Collaborate closely with Biosimilar Statisticians and other functional team members
Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans
Review and approve analysis dataset specifications
Review or contribute to data management plans, database development, and edit checks plan
Requirements
BA/BSc or higher degree in quantitative or scientific subjects
Nice to have: MSc or higher degree in quantitative or scientific subjects
Provide experienced technical expertise to develop process methodology for department to meet internal and external clients’ needs.
Responsibilities
Perform, plan and co-ordinate the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries
Program and plan the integration of databases from multiple studies or sources
Develop and co-ordinate programming documentation including plans and specifications for complex studies
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department for complex studies
Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications