Description
Project Need: A new, accelerated funding deadline requires additional support for a Phase IV study, necessitating a "stopgap" hire.
Role Focus: The position requires top-notch PK/PD skills for target attainment analysis, PopPK modeling, model refinement, and evaluation with biological interpretation.
Software Usage: The team uses R for processing NONMEM output and iterating, with SAS for final summaries.
Position Overview
Seeking an experienced PK/PD Biostatistician Contractor to support a time sensitive, NIH funded Phase IV research program with a hard funding deadline. This role is a stop gap engagement to address an unexpected compression of end of study timelines, where current internal resources are insufficient to meet deliverables.
The work supports a critically ill ICU patient population and focuses on advancing dosing recommendations for antibiotics in the setting of rapidly changing renal function. The project leverages a radiotracer based direct measurement of renal function, with the goal of evaluating and comparing GFR equations to inform dosing guidance and potential changes to clinical practice.
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Contract Details
•   Contract Type: Independent Contractor / Consultant
•   Expected Start: June 1 (workload increases meaningfully at that point)
•   Duration: Targeting up to 6 months, with a hard funding stop on 11/30
•   Extension: Possible short extension through year end for final processes and code archiving, but should not be assumed
•   Conversion: Not expected
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Project Scope & Responsibilities
•   Lead and independently execute population PK modeling activities using NONMEM
•   Refine and evaluate pre defined population PK models, including:
o   Covariate evaluation
o   Model refinement
o   Predictive performance comparison
o   Biological and clinical interpretation of results
•   Perform PK simulations to support dosing evaluations and comparative analyses
•   Support Phase IV analyses aimed at informing changes to dosing guidelines and clinical practice
•   Collaborate internally with cross-functional teams supporting NIH funded research
•   Utilize R extensively for model diagnostics, output processing, and iterative modeling decisions
•   Interface with SAS programming support for final summaries and deliverables as needed
•   Contribute to end of study deliverables, including analyses supporting CSR related outputs
•   This role is primarily internal facing; minimal to no external client interaction expected
Additional Skills & Qualifications
Candidate Profile: They seek an independent model developer, ideally with a PhD and 3-5 years of experience, but a Master's with sufficient experience is acceptable.
Required Skills & Experience
Top Required Skills
•   NONMEM (expert level; ability to efficiently build and manage control streams)
•   Population PK modeling
•   PK simulations
Additional Requirements
•   Strong PK and PD expertise with the ability to work independently
•   Experience developing, refining, and evaluating population PK models
•   Strong understanding of model diagnostics and predictive performance evaluation
•   Proficiency with R for NONMEM output processing and modeling iteration
•   Working knowledge of SAS (primary summaries supported by SAS programmers)
•   Ability to operate in a compressed timeline with fixed funding deadlines
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Preferred Qualifications
•   Phase IV experience (ideal but not required with strong PK background )
•   Familiarity with critically ill or ICU populations
•   Experience with renal function modeling or antibiotic PK (e.g., beta lactams) is a plus
•   Exposure to CDISC / ADaM programming is a bonus but not required
•   Prior experience on NIH funded or government sponsored research
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Education
•   PhD preferred with 3–5 years of relevant post degree experience
•   Master’s level candidates considered if they demonstrate strong independent PK modeling capability
Job Type & Location This is a Contract position based out of Rockville, MD.
Pay and Benefits The pay range for this position is $70.00 - $95.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type This is a fully remote position.
Application Deadline This position is anticipated to close on Apr 7, 2026.
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$70-$95 per hour Employment Type: CONTRACTOR