Date: 21-Feb-2012
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Biostatistical Programming Manager
• Function as study lead programmer on one or more Phase 2 and 3 clinical trials:
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 study level
• Review and approve 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
• Understand and execute department, product, and study-level macros and utilities
• Write and validate study and product-level macros and utilities
• Assist with study and systems audits by Global Compliance Auditing (GCA) and external bodies, and respond to audit questions and findings
• Participate in or lead technical programming and process improvement initiatives within and across functions
• Participate in the development and review of GBDS policies, manuals, standard operating procedures, and other controlled documents
• May manage and develop a small number of programming staff
• Provide support to and mentor more junior programmers
• 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
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
Preferred Qualifications Bachelor’s or Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences or other related scientific subject
Six (6) years clinical research and development programming experience
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
