Senior PK Analyst

Parexel; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a PK/PD programmer in the United States to support clinical development with SAS and/or R. You will derive PK/PD parameters, program datasets, and generate analyses and listings under GMP/ICH standards.

Ideal candidates have 4–6 years of relevant experience, expert SAS (or R) skills, and familiarity with Phoenix WinNonlin. Strong communication and project management are essential.

Qualifications

• 4-6 years relevant experience.
• Expert knowledge of SAS (SAS/Base, SAS/STAT, SAS/GRAPH) or R or both.
• Experience with Phoenix WinNonlin or equivalent.
• Knowledge of pharmacokinetic data.
• Understand regulatory requirements concerning industry technical standards.

Responsibilities

• Derivation of PK/PD parameters.
• Programming/validation of SAS/R datasets and PK/PD derived datasets.
• Reports: tables, listings, figures, and statistical appendices when applicable.
• Ensure deliveries meet specifications and timelines.
• Mentor less experienced analysts and share knowledge.

Skills

SAS programming

R programming

MS Office

Unix/Linux

English communication

Project management

Detail-oriented

Team mentorship

Problem solving

Education

Bachelor's degree in programming, statistics or mathematics

Tools

Phoenix WinNonlin

SAS

R

Job description

When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

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