Principal Statistical Programmer (SAS Viya, - Europe Only)

Overview

Principal Statistical Programmer supporting Biostatistics and other departments with statistical programming, with a focus on migration to SAS Viya. Europe only.

What you'll do

• Provide statistical programming technical support and expertise across the Biostatistics function and other departments as needed.
• Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Propose and lead the development of process improvements, programming tools and macros for standardization and efficiency, and new concepts, technologies and products to meet emerging customer needs.
• Analyze information and develop innovative solutions to programming and data analysis challenges across the department.
• Review, provide input on, and promote standardization of CRFs, databases, Statistical Analysis Plans and mock shells within a project or therapeutic area, or across a program.
• Mentor other members of the Biometrics Department in traditional, new, and novel approaches to delivering analytics to sponsors and regulatory agencies through training courses and one-on-one discussion.
• Understand and enforce compliance with company, regulatory, and industry standards, within and across projects or programs.
• Develop or review specifications and support any kind of statistical programming activity.
• Negotiate and establish accurate time estimates for project completion with internal team members and statistical programming management, provide regular status updates, and complete projects within agreed timeframes.
• Maintain well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Act as primary customer interface representing the department at client meetings and present status updates at Senior Management meetings.
• Work with others, hold project team members accountable, and lead projects and initiatives as necessary to meet business needs.
• Provide project oversight to Lead Statistical Programmers across one or more programs.
• Maintain extensive working knowledge of clinical drug development, industry standards, and electronic submission requirements.
• Actively participate in industry standards organizations and provide regular updates to the Biometrics Department on upcoming changes to those standards; contribute to presentations at industry conferences and roundtables.
• As a subject matter expert for CDISC and other industry and regulatory requirements, perform compliance reviews of project deliverables, including SDTM and ADaM specifications and datasets and regulatory required documents (e.g. DEFINE.XML).
• Lead or support the development of Standard Operating Procedures (SOPs), guidelines, policies, and/or procedures; follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Support business development activities by contributing to proposals, requests for information, budgets, and attending sponsor bid defense meetings.
• Perform other work-related duties as assigned.

Details

• Location: Remote, United Kingdom (Europe only).
• Minimal travel may be required.