Senior PK Analyst

• Derive pharmacokinetic and pharmacodynamic parameters
• Program and validate NONMEM datasets and PK/PD-derived datasets
• Program and validate tables, listings, figures, and statistical appendices where applicable
• Execute activities according to agreed SOPs and timelines while maintaining quality
• Ensure deliverables match agreed specifications and expectations
• Apply good programming practices according to ICH and GCP standards
• Provide training and guidance and mentor less experienced analysts
• Check own work and others’ work to ensure first-time quality
• Maintain a positive, results-oriented work environment and promote teamwork
• Participate in or lead process and quality improvement initiatives
• Represent CPMS on cross-functional initiatives
• Lead knowledge-sharing forums and support wider departmental development
• Serve as process or system owner for development, implementation, and maintenance in collaboration with stakeholder functions such as IT Technology and Quality

• 4-6 years relevant experience
• Expert programming skills with a focus on SAS or R programming
• Advanced skills in Microsoft Word, Excel, PowerPoint, and Outlook
• Experience with Phoenix WinNonlin or equivalent
• Knowledge of pharmacokinetic data
• Understanding of regulatory requirements concerning industry technical standards
• Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R or both
• Bachelor’s degree or equivalent in a programming, statistics, or mathematics discipline is preferable
• Postgraduate qualification is advantageous
• Good standard of written and spoken English
• Ability to learn new systems and function in an evolving technical environment
• Professional attitude, self-motivated, logical thinking
• Excellent attention to detail
• Excellent interpersonal, verbal, and written communication skills
• Strong project management skills
• Client-focused approach to work ethic
• Ability to manage multiple and varied tasks, independently prioritize workload, and adapt to change
• Ability to negotiate and influence to achieve results
• Ability to resolve complex issues creatively and effectively
• Ability to work well under pressure and meet scheduled timelines
• Ability to work with line and middle management on a functional level