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• BSc or higher in mathematics, statistics, computer science or related discipline.
• Recognized expertise in SAS programming and SAS macro code development. Understanding of other SAS products (e.g. SAS/GRAPH, SAS Output Delivery System).
• A thorough understanding of the end to end clinical trial process.
• 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.
• Effective written, verbal communication skills and demonstrated interactions across clinical teams.
• Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions).
• Project management or relevant experience.
• Ability to manage conflicting demands and priorities and to negotiate successfully.
• Knowledge of basic computer skills (MS Word, Excel, PowerPoint, Outlook).
• Knowledge of non-SAS programming packages/languages (e.g. Spotfire, S-Plus, R).
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development at UK and US sites. The Quantitative Sciences division includes a Clinical Programming department, sitting within the broader Clinical Statistics group, covering all phases of clinical drug development and commercialisation in a wide range of therapeutic areas. In recognition of the developing sophistication and technical requirements of the role, Clinical Programming was formed as a standalone department distinct to Clinical Statistics. 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 Programming Manager will act as a lead clinical 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.
The successful candidate will be involved with a diverse range of activities including:
• 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 ensures their performance meets the agreed timelines, quality and budget requirements established for the project or study.
• Defines, develops and embeds 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
• Acts as key statistical programming contact for internal and external business partners.
• Provide technical advice to other teams and departments and 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 face of unusual and conflicting information.
• Provide broader technical knowledge and expertise (e.g. UNIX scripting, computing environments).
• Appreciate future direction/wider objectives of project or business. Anticipate future challenges.
• Identify recurring problems and initiates process improvement.
• Provide oversight, training and performance feedback to less senior programmers.
• Lead non-clinical projects within department or across the wider Statistics and Programming community.
• Lead and progress project and non-project activities concurrently.
• Encourage and embed key behaviours from staff. Build credibility and presence with internal and external customers.
Closing date for applications: Friday 22nd December 2017.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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