Senior PK Analyst

This is a fully remote position, open to applicants in South Africa, +3 more countries.

📋 Description

• Deliver technical support and expert guidance to both internal and external stakeholders, including sponsors and the Clinical Pharmacology, Modelling & Simulation (CPMS) team.

• Calculate Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters.

• Develop and validate NONMEM datasets along with PK/PD derived datasets.

• Create and validate tables, listings, figures, and statistical appendices as required.

• Carry out activities in accordance with established SOPs and timelines while ensuring quality standards.

• Ensure that outputs meet the agreed specifications and expectations.

• Implement good programming practices in line with International Conference on Harmonization and Good Clinical Practice guidelines.

• Engage in and/or lead initiatives focused on process and quality improvement.

• Act as the process/system owner for the development, implementation, and maintenance of processes/systems, collaborating with stakeholder functions.

• Provide programming support, query resolution, mentoring, and training to other analysts.

• Work independently on clinical development projects of varying degrees of complexity.

⛳️ Requirements

• 4-6 years of relevant experience.

• Proficient knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R, or both, with a preference for R.

• Experience with Phoenix WinNonlin or a comparable tool.

• Familiarity with pharmacokinetic data.

• Advanced proficiency in Microsoft applications.

• Understanding of regulatory requirements related to industry technical standards.

• Knowledge of Unix and/or Linux is a plus.

• Capability to learn new systems and thrive in a dynamic technical environment.

• Professional demeanor, self-motivated, and possesses logical reasoning skills.

• Exceptional attention to detail.

• Strong interpersonal, verbal, and written communication abilities.

• Adept project management skills.

• Client-focused work ethic.

• Ability to manage multiple diverse tasks, prioritize workload independently, and adapt to changes.

• Good command of written and spoken English.

• Proficiency in negotiation and influencing to achieve desired outcomes.

• Skill in resolving complex issues in innovative and effective manners.

• Capacity to perform well under pressure and adhere to scheduled timelines.

• Ability to collaborate with line and middle management at a functional level.

• A Bachelor's degree or equivalent in a programming, statistics, or mathematics-related field is preferred.

• A postgraduate qualification is an advantage.

🏝️ Benefits

• Comprehensive health insurance.

• Retirement savings plan with employer matching.

• Flexible working hours and remote work options.

• Continuous professional development opportunities.

• Collaborative and innovative work environment.