Senior PK Analyst

This is a fully remote position, open to applicants in China, +1 more country.

📋 Description

• Extract pharmacokinetic and pharmacodynamic parameters

• Develop and validate NONMEM datasets as well as PK/PD-derived datasets

• Create and validate tables, listings, figures, and statistical appendices when applicable

• Carry out tasks in accordance with established SOPs and timelines while ensuring quality

• Verify that deliverables align with agreed specifications and expectations

• Implement good programming practices in line with ICH and GCP standards

• Offer training, guidance, and mentorship to less experienced analysts

• Review personal and peer work to guarantee first-time quality

• Foster a positive, results-driven work atmosphere and encourage teamwork

• Engage in or spearhead process and quality enhancement initiatives

• Represent CPMS in cross-functional projects

• Facilitate knowledge-sharing sessions and support broader departmental growth

• Act as the process or system owner for development, implementation, and maintenance in collaboration with stakeholder functions such as IT Technology and Quality

⛳️ Requirements

• 4-6 years of relevant experience

• Proficient programming skills with a specialization in SAS or R programming

• Advanced proficiency in Microsoft Word, Excel, PowerPoint, and Outlook

• Experience with Phoenix WinNonlin or similar software

• Familiarity with pharmacokinetic data

• Understanding of regulatory requirements related to industry technical standards

• In-depth knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R, or both

• A Bachelor’s degree or equivalent in programming, statistics, or mathematics is preferred

• A postgraduate qualification is a plus

• Strong command of written and spoken English

• Ability to learn new systems and adapt in a changing technical environment

• Professional demeanor, self-motivated, and logical thinker

• Exceptional attention to detail

• Strong interpersonal, verbal, and written communication skills

• Robust project management capabilities

• Client-focused work ethic

• Capacity to manage multiple tasks, prioritize workload independently, and adapt to changes

• Ability to negotiate and influence to achieve desired outcomes

• Skill in creatively and effectively resolving complex issues

• Competence in working well under pressure and meeting deadlines

• Ability to collaborate effectively with line and middle management on a functional level

🏝️ Benefits

• Comprehensive health insurance options

• Opportunities for professional development and training

• Flexible working arrangements

• Competitive salary and performance-based incentives

• Supportive and collaborative work environment