Biostatistical Programming Lead in England - Cambridge, United Kingdom

at Amgen

Minimum Qualification
Bachelor's Degree
Required Experience
7 - 10 years
Employment Type
Full Time
Male or Female
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Job Description

• Programming, validation, and documentation support for the ongoing maintenance of the Global Statistical Programming (GSP) Standard Macro Library. The Standard Macro Library consists of SAS macros that generate word processor ready tables, listings, and figures. The macros are utilized by GSP study programming teams to automate all of the programming steps needed to produce the tables, listings, and figures used for reporting clinical trials results. 

• Programming, validation, and documentation support for the Operational Excellence (OE) Tables, Figures, and Listings (TFL) Process Improvement initiative. The initiative aims to re-architect, modernize, and refine the software development processes and tools used to produce TFL utilities in order to reduce code volume and complexity, and to increase efficiency in the delivery and execution of these utilities. 

• Provide support to study lead programmers on one or more Phase 2 and 3 clinical trials including the following activities: 
o set up the study-level programming environment 
o project-manage programming activities on the study, ensuring quality and timeliness 
o ensure all programming activities on the study adhere to required standards
o represent GSP and provide input to multidisciplinary team and department meetings 

• Create, or review and approve, programming specifications and plans at the department level 

• Understand and utilize key study-related documents produced by other functions, such as case report forms, data management plan, and statistical analysis plan 

• Write and validate SAS programs using CDISC standards to produce permanent datasets and presentation-ready output, to be included in reports for submission to regulatory agencies, publications and other communications

• Assist with the development, review, and validation of study and product-level macros and utilities 

• Participate in or lead technical programming and process improvement initiatives within and across functions 

• Participate in the development and review of GBS policies, manuals, standard operating procedures, and other controlled documents 

• Possible opportunities to manage and develop a small number of contract programming staff 

• Provide support to and mentor more junior programmer 

• Participate in the recruitment of GSP staff and contractors 

• Promote and communicate awareness of biostatistical programming and the role of the GSP department in internal and external professional organizations, conferences, training, or meetings


• Bachelors degree with significant directly related experience 
• Biostatistical programming using the SAS System version 8.2 and higher 
• Understanding of computer operating systems, including UNIX, preferred 
• Project planning and management 
• Drug development process & operations

Preferred Qualifications

• Bachelors or Masters degree in Computer Science, Statistics, Mathematics, Life Sciences or other related scientific subject 
• Significant clinical research and development programming experience 
• Cardiovascular and/or nephrology therapeutic area programming experience a plus 
• CDISC experience 
• Drug Development (pre-, early, late and/or observational) in related industries 
• Project planning 
• Process improvement participation 
• Team participation and effectiveness

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