Career CategoryClinicalJob Description
The Biostatistical Programming Manager will work in Amgen's Global Randomization and Blinding (GRB) organization and can be based at Amgen's headquarters in Thousand Oaks, California or at Amgen's South San Francisco or can be remote.
Write and validate SAS programs to verify randomization assignments and dose decisions performed by IRT (Interactive-Response-Technologies) system throughout the conduct of the clinical trial.
Function as study programmer to manage IRT Data transfer (DTs) activities
Provide leadership and primary responsibility for IRT DTs activities including receipt, review, tracking, and delegation of IRT DTs verification requests
Maintain IRT DTs application (Wrapper/Bridge tool)
Identify and champion IRT DTs process improvements as necessary.
Ensure effective procedures are in place for verifying IRT DTs.
Ensure Study Randomizers are sufficiently trained to perform IRT DTs verification activities
Investigate, research, and develop IRT DTs verification methods to meet Amgen and regulatory requirements
Provide cross functional training and/or instruction on topics related to IRT DTs verification.
Collaborate with and represent GRB on cross functional teams to ensure the maintenance and continual improvement of procedures and training relating to IRT DTs verification.
Arbitrate and consult with cross functional teams on issues related IRT DTs verification.
Collaborate with and represent GRB on cross functional teams to ensure the maintenance and continual improvement of procedures and training relating to IRT data verification.
Act as a Gatekeeper for IRT data transfers into Amgen sFTP locations.
Understand and execute department level macros and utilities
Write and validate study level macros and utilities
Perform the duties of a Study Randomizer as needed
Ensuring randomization requests are consistent with study protocol and study specific IRT Business Requirements
Creating and delivering Subject and IP (Investigational Product) Box randomization lists meeting specifications per randomization requests
Verifying electronic system loads
Ongoing verification of electronic system execution of randomization schedules and dosing algorithms
Ensuring procedures are followed to maintain the study blind per Amgen SOPs throughout the life of the study
Maintaining accurate and complete documentation of randomization and blinding activities and communications
Serving as subject matter expert to impact randomization specifications ensuring optimal randomization strategies for all Amgen studies
Providing training to for other randomizers as necessary
Identifies areas for improvement and create strategies for implementing process improvements
Assist with study and systems audits by Global Compliance Auditing (GCA) and external bodies, and respond to audit questions and findings
Participate in the development and review of GRB policies, manuals, standard operating procedures, and other controlled documents
Provide support to and mentor more junior programmer
Promote and communicate awareness of biostatistical programming and the role of the GRB department in internal and external professional organizations, conferences, training, or meetings
Biostatistical programming using the SAS System version 8.2 and higher
Understanding of computer operating systems, including UNIX, preferred
Project planning and management
Basic understanding of IRT systems, preferred.
Drug development process & operations
Bachelors or Masters degree in Computer Science, Statistics, Mathematics, Life Sciences or other related scientific subject
Six (6) years clinical research and development programming experience
Drug Development (pre-, early, late and/or observational) in related industries
Process improvement participation
Team participation and effectiveness
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.