Amgen Global Randomization and Blinding (GRB) Head in Thousand Oaks, California

The GRB Head provides the effective development, application, deployment, and documentation of randomization and blinding activities of Amgen clinical trials. This role provides overall leadership and subject matter expertise on topics related to randomization and blinding for cross functional Amgen colleagues and groups; and initiates and leads maintenance and improvement efforts for GRB and cross functional processes and standards related to the randomization and blinding of Amgen clinical trials.

Key responsibilities of the GRB Head include:

  • Provide leadership and primary responsibility for GRB activities including receipt, review, tracking, and delegation of subject and IP box randomization schedule requests

  • Maintain RandGen and RTS IS systems

  • Identify and champion IS system improvements

  • Ensure effective procedures are in place for maintaining the study blind

  • Supervise and manage dedicated full time Study Randomizers

  • Provide backup support for existing randomizations when the assigned Study Randomizer is unavailable

  • Ensure Study Randomizers are sufficiently trained to perform randomization and blinding activities

  • Initiate and champion process improvements as necessary

  • Investigate, research, and develop randomization and blinding methods to meet Amgen and regulatory requirements

  • Provide cross functional training and/or instruction on topics related to randomization and blinding

  • Collaborate with and represent GRB on cross functional teams to ensure the maintenance and continual improvement of procedures and training relating to randomization and blinding

  • Arbitrate and consult with cross functional teams on issues related to randomization and blinding

  • Position has all the responsibilities of a full time study randomizer

Key decision-making authorities of the GRB Head:

  • Decisions impacting RandGen and RTS IS systems functionality

  • Decisions affecting development of standard documents and processes

  • Decisions regarding user access to Unix groups, GRB e-mail folders, RandGen, and RTS

  • Resource planning

  • All decision making authority granted to a study randomizer

Key activities of the GRB Head include the following:

  • Provides support to individual studies on unique or escalated GRB issues

  • Ensures current practices adhere to GRB related controlled documents

  • Reviews and updates GRB Group authored controlled documents as appropriate

  • Ensures proper documentation of GRB activities

  • Maintains good communication within the GRB Group through regular group meetings, e-mails, etc.

  • Ensures sufficient staff are in place to meet GRB Group needs through recruitment and coordination of current staff

  • Provides oversight and maintenance of training materials related to GRB activities for group members as well as other functional and cross-functional representatives

  • Reviews and provides input on controlled documents that include GRB related activities that are owned by cross functional organizations

  • Communicates GRB issues to line management

  • Participates in task forces, Good Practices Work Streams, Workshops and Advisory Teams where randomization and blinding in clinical trials may need to be addressed

  • Maintains good communication with internal and external business partners to create and maintain standards and address concerns related to randomization and blinding

Basic Qualifications

Doctorate degree and 2 years of Biostatistics experience

OR

Master's degree and 6 years of Biostatistics experience

OR

Bachelor's degree and 8 years of Biostatistics experience

Preferred Qualifications

  • Master's or doctorate degree in Statistics/Biostatistics related subjects with highly statistical or statistical programming contents

  • At least 5+ years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting

  • Statistical expertise and leadership in clinical trial randomization and blinding

  • Excellent computing skills using SAS or applicable randomization software package

  • Experience with the IxRS system and vendor management Drive for innovation and quick adaptation to new industry trends

  • Well recognized leadership among randomizers and cross-functional teams

  • Strong technical and effective communication skills

  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

  • Knowledge of relational databases

  • Extensive SAS programming experience

  • Experience in using SAS Enterprise Guide

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.