Senior PK Analyst
Primary Location: China, Remote Additional Locations: Taiwan, Remote 求人ID R0000046948 Category Medical Affairs
About this Role
Key Accountabilities:
- Derivation of Pharmacokinetic (PK), and Pharmacodynamic (PD) parameters.
- Programming and validation of NONMEM datasets and PK/PD derived datasets.
- Programming and validation of tables, listings, figures, and statistical appendices if applicable.
- Execute activities according to the agreed processes (SOP’s) and timelines while maintaining good quality.
- Ensures that the deliveries match the agreed specifications and expectations.
- Apply good programming practices; works according to International Conference on Harmonization and Good Clinical Practice standards.
- Provides training and guidance and act as a mentor to less experienced analysts.
- Checks own work and the work of others to ensure first-time quality.
- Maintain a positive, results orientated work environment, building partnerships, and promoting teamwork
- Proactively participate in and/or lead process/quality improvement initiatives.
- Represent CPMS on cross-functional initiatives
- Lead knowledge sharing forums and proactively support the development of the wider department.
- May serve as process/system owner responsible for development, implementation and maintenance of process/systems in collaboration with key stakeholder functions (e.g. IT Technology, Quality)
Skills:
- Expert programming skills (with a focus on SAS or R programming).
- Advanced skills in Microsoft applications (Word, Excel, PowerPoint, Outlook)
- Unix and/or Linux knowledge is advantageous.
- 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 with enthusiasm and independently prioritize workload, demonstrated flexibility to change.
- Good standard of written and spoken English
- Ability to negotiate and influence to achiever results.
- Ability to resolve complex issues in creative and effective ways.
- Ability to work well under pressure and to keep to scheduled timelines.
- Ability to work with line- and middle-management on a functional level.
Knowledge and Experience:
- 4-6 years relevant experience
- Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R or both
- Experience with Phoenix WinNonlin or equivalent
- Knowledge of pharmacokinetic data
- Understand regulatory requirements concerning industry technical standards
Education:
- A bachelor’s degree or equivalent in a programming, statistics or mathematics discipline is preferable. Post graduate qualification is advantageous
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