Senior PK Analyst – R Programmer
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Job Description
Senior PK Analyst programming and validating PK/PD datasets, tables, and figures for Parexel’s clinical development and clinical trial solutions. Supporting sponsors and mentoring analysts.
Responsibilities:
- Provide technical support and expert advice to internal and external stakeholders, including sponsors and the Clinical Pharmacology, Modelling & Simulation team
- 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 in accordance with ICH and GCP standards
- Participate in and/or lead process and quality improvement initiatives
- Serve as process or system owner for development, implementation, and maintenance of processes or systems with stakeholder functions
- Work independently on clinical development projects of varying complexity
- Support other analysts through programming assistance, query resolution, mentoring, and training
Requirements:
- 4–6 years of programming experience using SAS and R
- Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) and R
- Advanced skills in Microsoft applications
- Experience with Phoenix WinNonlin desirable
- Knowledge of pharmacokinetic data desirable
- Understanding of regulatory requirements concerning industry technical standards
- Unix and/or Linux knowledge 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, prioritize workload independently, and adapt to change
- Good standard of written and spoken English
- 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
- Bachelor's degree or equivalent in programming, statistics, or mathematics is preferable
- Postgraduate qualification advantageous
Benefits:
- Remote work arrangement
- Full-time employment
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