Pharmacokinetic Analyst Jobs

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team a PK Analyst for our Markham, Ontario on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.
Summary
This position is accountable for performing non-compartmental (NCA) pharmacokinetic (PK)/pharmacodynamic (PD) data analyses and preparation of PK/PD outputs using Phoenix WinNonlin. This position may also support preparation of PK Analysis Plans and PK/PD reports.
This position is part of our Clinical Pharmacology and Drug Development department. A summary of the services this department provides can be found here: Clinical Pharmacology and Drug Development
Responsibilities Include

• Assist with development of PK Analysis Plans, as needed.
• Conduct PK/PD data analysis in Phoenix WinNonlin and/or NLME for Phase I-III clinical trials.
• Develop templates to generate tables/listings/figures (TLFs) for standalone PK/PD reports using WinNonlin functionality.
• Plan and carry out professional development.
• Play an active role on cross-functional project teams as a clinical pharmacology team member, interacting with PK Scientists, Biostatisticians, and Project Managers for the execution and management of Phase I-III clinical trials.
• Author and/or review standalone PK/PD Reports, or PK/PD section of Clinical Study Reports.
• Maintain PK project tracker and update project list as needed.
• Prepare PK/PD summary reports and outputs (tables/figures) from the NCA analyses utilizing WinNonlin functionality.
• Perform exploratory PK/PD data analysis in Phoenix WinNonlin and/or NLME for Sponsors as needed.
• Maintain current knowledge of pharmaceutical clinical research industry standards, conventions and regulatory requirements, as well as the knowledge of clinical trial sponsor-specific requirements when applicable.
• Participate in the development and maintenance of, and adhere to divisional Standard Operating Procedures (SOPs) and guidelines.
• Participate in the development and maintenance of, and adhere to therapeutic area specific standards and conventions.
• Document data and PK analysis information in accordance with Everest company SOPs and working instructions, and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.

Requirements Include
M.Sc. in Clinical Pharmacology (including Pharmacokinetics, Pharmacodynamics), Pharmacy, Biopharmaceutics or related field.
Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
Proficient in using WinNonlin, for non-compartmental analysis of PK/PD data.
Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
Skilled in scientific writing and PK data interpretation.
Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing.
Demonstrated ability for logical thinking, vision, and creativity necessary to function effectively with a large degree of independence and little supervision.
Ability to multi-task, manage multiple projects with competing and aggressive timelines.
Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
Well organized and able to work independently.
Strong understanding of fundamental pharmacokinetic and statistical principles.