Biostatistical Programming Manager
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
- Doctorate degree in Computer Science, Statistics, Mathematics, or Life Sciences
- Master's degree and 3 years of Computer Science, Statistics, Mathematics, or Life Sciences
- Bachelor's degree and 5 years of Computer Science, Statistics, Mathematics, or Life Sciences
- 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
- Project planning
- Process improvement participation
- Team participation and effectiveness