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For your reference, we have included the original job posting below.
Clinical Data Management Systems Manager - SAS Programming
Job Number:
41708850
Company Name:
Amgen
Job Location:
South San Francisco, CA US
Job Categories:
Clerical & Administrative Research
Clinical Data Management Systems Manager - SAS Programming
The CDM Systems Manager (CDM SAS Programming) role resides in the CDM Systems organization of the Global Clinical Data Management department. The position can be based at either Amgen's headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site. However, the preference is that the candidate be located at Amgen's Thousand Oaks headquarters.
The key responsibilities of the CDM Systems Manager include the following:
• The Clinical Data Management Systems Manager will serve as the primary point-of-contact for Clinical Data Management Operations staff with responsibilities for CDM Systems SAS programming and electronic data acquisition deliverables. This will include: developing and validating SAS programs, macros and applications, data transfer plans, electronic data load and SAS checks. • This individual will coordinate, project and manage SAS and clinical data programming and electronic data acquisition activities in conjunction with the study team expectations and in accordance with standard operating procedures and regulatory agency guidelines. • This individual will be responsible for the procurement of resources for assigned programming tasks and will oversee the timely completion and quality of these assigned tasks. • They will provide technical expertise and leadership within Global CDM's SAS programming and/or electronic data interchange groups. • They will gather and analyze status and performance metric information. This manager will mentor and train junior staff. • They will contribute and may lead process development and improvement projects, both internal and external, to the Global CDM department. • They may support and respond to internal and external audit processes. • They will provide technical and business process input / expertise on new and emerging technologies/vendors for clinical trial execution • May also have some line management responsibilities
- Other tasks may include: o Ad hoc programming of data listings and custom reports o Programming of blinded data and review of tables and listings of blinded data. o Programming and support for compliance reports and internal audit requests.
Basic Qualifications • Doctorate degree • OR • Master's degree & 3 years of directly related experience • OR • Bachelor's degree & 5 years of directly related experience • OR • Associate's degree & 10 years of directly related experience • OR • High school diploma / GED & 12 years of directly related experience
Preferred Qualifications • Bachelors degree or equivalent in life science, computer science, business administration or related discipline or equivalent combination of education and experience • 6+ years work experience in data management / programming in the Pharmaceutical or Biotech arena • 3+ years project management and planning experience • Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, ETO vendors, etc.)
Experience:
• The ideal candidate has experience in multiple database management systems (preferably Medidata RAVE and Oracle Clinical) plus advanced knowledge of SAS, PL/SQL languages and Unix environment and has strong communication skills to maintain a high level of transparency between clinical study team members and CDM Systems programming staff. • 6 - 8 years experience in Data Management, Programming or Business Administration • 3+ years project management and planning experience
Knowledge: • Drug Development and Clinical Trials Processes • Data Management Processes • Good Clinical Practice • Clinical Trial Databases and Applications • Systems Development Lifecycle • Programming Languages (SAS, OC and PL/SQL) • Working knowledge of UNIX and scripting in UNIX • Project Management
Key Competencies • Effective Communication and Collaboration Skills • Analytical Skills • Problem Solving • Teamwork in a Matrix Environment • Attention to Detail • Strategic thinking • Ability to handle multiple projects at the same time