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• BSc or higher in mathematics, statistics, computer science or related discipline. Travel Required: Not Indicated
• Recognized expertise in SAS programming and SAS macro code development. Understanding of other SAS products (e.g. SAS/GRAPH, SAS Output Delivery System)
• A solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11
• Demonstrated knowledge of and experience in the application of CDISC data and standards, primarily the creation and use of ADaM datasets
• Knowledge of basic computer skills (MS Word, Excel, PowerPoint, Outlook)
• Knowledge of non-SAS programming packages/languages (e.g. Spotfire, S-Plus, R)
• Ability to manage conflicting demands and priorities and to negotiate successfully
• Project management or relevant experience
• Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g., working with CROs, academic institutions)
• Effective written and verbal communication skills
• Demonstrated direct interaction with clinical study team members of a consistently successful nature.
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies, with statisticians and programmers working at UK and US R&D sites, and worldwide. In recognition of the developing sophistication and technical requirements of the programming role, the Clinical Programming department was formed as a standalone department within the broader Clinical Statistics group 18 months ago, covering all phases of clinical drug development and commercialisation in a wide range of therapeutic areas. In addition to the group’s activities supporting GSK’s pipeline of drugs, key accountabilities include developing and implementing strategies for programming resourcing using both internal, external, onshore and offshore resource; driving CDISC implementation for the reporting of clinical trials; and identifying and implementing IT solutions to offer further benefit and efficiency for the group’s activities.
The Principal Programmer acts as a lead programmer for GSK clinical trials, accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards.
• Plan and manage programming activities across multiple studies, asset(s), indication or function to deliver all data analysis outputs to agreed timelines and quality, (e.g., analysis datasets, pooled datasets, tables, figures and listings for regulatory or reimbursement submissions and publications).
• Oversee outsourced tasks to third party vendors and ensure their performance meets the agreed timelines, quality and budget requirements established for the project or study.
• Define, develop and embed standards within a function, or therapeutic area in accordance with industry standards
• Responsible for programming and QC across a study/asset including submission activities.
• Review and input into key documents at the project level (e.g. submission documents, clinical reports and publications). May author or co-author reporting analysis plans and department level documents (e.g. SOPs, working practice document).
• Participate in the design of other study delivery components (e.g. case report forms, study databases).
• Provide tools that add value at study team and functional team level
• Act as key statistical programming contact for internal and external business partners.
• Work with other disciplines outside of the department to solve complex problems. Proactively identify, assess and resolve the impact of decisions/actions from other groups. Define criteria for assessing alternative solutions and determine the optimal approach. Make decisions in the face of unusual and conflicting information.
• Provide broader technical knowledge and expertise (e.g. UNIX scripting, computing environments). Provide technical advice to other teams and departments.
• Appreciate future direction/wider objectives of project or business. Anticipate future challenges.
• Identify recurring problems and initiate process improvement.
• Provide oversight, training and performance feedback to less senior programmers
You may apply for this position online by selecting the Apply now button.
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