Dear Allstat,
SEC Pharma is currently recruiting for a contract Statistical Programmer who will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors.
You will liaise with Sponsors, Data Management, Biostatistics and other functional areas as required and monitor quality, timelines, resource allocation, and productivity in relation to budgets.
Main Responsibilities includes:
• Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
• Ensure quality control on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, SOPs guidelines, ICH-GCP and/or other international regulatory requirements are
performed.
• Maintain all supporting documentation for studies in accordance with SOPs guidelines to ensure traceability and regulatory compliance.
• Be trained in sponsor SOP’s and disseminate knowledge to project team members as appropriate.
• Proactively participate in and lead process/quality improvement initiatives.
• Work closely with the Quality Management Groups to ensure compliance with SOPs guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
• Maintain and expand local and international regulatory knowledge within the clinical industry.
• 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 the company and sponsors.
• Provide broad support, including advice on new technologies and industry technical standards (e.g. CDISC) and their integration into Programming processes.
• 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).
• 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 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.
For immediate consideration – please send your updated CV to
[log in to unmask] or call +44(0)207 255 6665 for a confidential discussion.
Best regards,
Priya
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