Pharmacologist (PK Analyst)

Job#: 3025571

Job Description:
Position: Pharmacologist / Pharmacokinetic (PK) Analyst

Location: 100% Remote

Duration: ~2-3 months contract

Position Overview

We are seeking a Pharmacologist / PK Analyst to perform baseline-adjusted PK analysis for an at-home use clinical study evaluating nicotine uptake across multiple oral products.

You will receive bioanalytical outputs and raw datasets and generate PK parameters, PK curves, and Tables/Figures/Listings (TFLs) comparing products.

Key Responsibilities

• Perform baseline-adjusted pharmacokinetic (PK) analyses on clinical study data (ADME/PK focus with emphasis on exposure over time).
• Conduct PK parameter derivations (e.g., Cmax, Tmax, AUC, elimination metrics as appropriate) and produce individual and mean profiles.
• Build and deliver Tables, Figures, and Listings (TFLs) including:
  • Descriptive summaries (means/averages, variability)
  • Individual-level PK curves
  • Product-to-product comparisons
• Use Phoenix WinNonlin (Certara) and/or SAS to execute analysis and ensure reproducible outputs; adapt analysis to client platforms as needed.
• Handle data hygiene/QC: reconcile subject/timepoint data, baseline adjustments, outlier checks, missingness, and documentation of assumptions.
• Partner with clinical/site stakeholders and bioanalytical lab partners to resolve data queries and ensure analysis readiness (e.g., final sample shipments, lab result timing).
• Create a concise PK analysis report and a leadership-ready summary/roadshow deck demonstrating outputs and recommended "future-state" analysis workflow.

Must Haves

• Advanced degree in Pharmacology, Pharmaceutical Sciences, Biostatistics, or related discipline (MS/PhD/PharmD preferred).
• Proven experience performing clinical PK analysis (noncompartmental analysis strongly preferred).
• Hands-on expertise with Phoenix WinNonlin and/or strong SAS programming for clinical/statistical analysis datasets and outputs.
• Experience producing TFLs (tables/listings/figures) for clinical study deliverables.
• Strong documentation/QC mindset; ability to explain methods clearly to technical and leadership audiences.

Nice to Have

• Exposure PK experience and/or familiarity with oral nicotine products.
• Experience with at-home use study data variability and compliance considerations.
• CDISC familiarity (SDTM/ADaM) a plus.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.