Principal Statistical Programmer



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The Principal Statistical Programmer will be recognized as a subject matter expert providing technical support and expert advice to internal and external sponsors. In addition, the Principal Statistical Programmer can liaise with sponsors, Data Operations Leads, and other functional areas as required. Monitor quality, timelines, resource allocation, productivity and budgets. Deliver best value and high quality service. The Statistical Programmer will: o Input into and negotiate programming timelines. Ensure that timelines are adhered to. o Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget o Monitor project resourcing, project budgets, and identify changes in scope - Ensure quality control on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed. - Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance Be trained in sponsor WSOP- and disseminate knowledge to project team members as appropriate. - Proactively participate in and/or lead process/quality improvement initiatives - Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required - Develop wider knowledge of areas of Clinical Data Management Systems (CDMS) Electronic Data Capture (EDC) Clinical Trial Management System (CTMS) Safety Reporting, SAS, SQL,and other programming language usage and processes within the GRO, biostatistics, and medical arenas - Assist project teams in the resolution of problems encountered in the conduct of their daily work - Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both PAREXEL and sponsors - Provide broad support, including advice on new technologies and industry technical standards (e.g. EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies etc) and their integration into Programming processes - Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities Provide consultancy to internal and external sponsors with regard to statistical programming tasks. In addition, maintain visibility to these sponsors to ensure expectations are being met and that requirements are accurately distributed to the appropriate stakeholders - Provide oversight and guidance on multiple-trial programs, complex trials and submission projects (including Integrated Summary of Safety or Efficacy) - Coordinate project start-up activities, creation of global programs (e.g., etc), tracking spreadsheets and required documentation - Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents - Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings - Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions etc) and implications for the department - Create standard macros and applications to improve the efficiency - Assessment of technology and processes, facilitate best practices, increase quality, efficiency and productivity - Consult with sponsors on technical/regulatory issues - Represent PAREXEL at sponsor marketing and technical meetings - Mentor and train other members of the department.


In-depth SAS programming experience - Previous SAS Project leadership experience required - Proven record of leading a team and large scope of projects in a GRO, Technical, Clinical, Medical or Statistical environment
Additional Information
Location | | | Sheffield Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013

Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided


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