Remote Senior PKPD Programmer/Analyst Consultant -Onsite at Upper Gwynedd, PA

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior PKPD Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Job Summary

We are seeking an experienced Senior PK/PD Programmer to support pharmacokinetic (PK) and pharmacodynamic (PD) analyses across clinical development programs. This role is responsible for creating analysis datasets, generating tables/listings/figures (TLFs), supporting modeling activities, and ensuring high-quality deliverables for regulatory submissions. The ideal candidate has strong programming expertise (SAS and/or R), experience with NONMEM or other modeling tools, and a solid understanding of clinical pharmacology.

Key Responsibilities

Programming & Analysis

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  Develop and validate PK/PD analysis datasets (ADaM, SDTM as applicable).



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  Generate Tables, Listings, and Figures (TLFs) for PK/PD studies.



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  Support population PK, exposure-response, and other modeling analyses.



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  Perform data cleaning and reconciliation between clinical and PK datasets.



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  Ensure compliance with CDISC standards (SDTM, ADaM).

Modeling Support

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  Support pharmacometricians in NONMEM, Monolix, or similar modeling platforms.



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  Prepare analysis-ready datasets for modeling.



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  Assist with model diagnostics, simulations, and reporting outputs.



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  Create graphical outputs for clinical study reports and regulatory submissions.

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  Perform QC and validation of programming outputs.



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  Support regulatory submissions (IND, NDA, BLA, etc.).



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  Maintain documentation for programming activities.

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  Work closely with Clinical Pharmacology, Biostatistics, Data Management, and Medical Writing teams.



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  Participate in study team meetings and provide programming input.



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  Mentor junior programmers when needed.

Qualifications & Experience

Experience

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  5–8+ years of programming experience in clinical trials.



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  3+ years of PK/PD programming experience.



• Experience with NMPKPD and ER datasets.


• Experience in Early-Stage Development studies.


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  Experience with R programming preferred.



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  Working knowledge of NONMEM, Monolix, Phoenix WinNonlin, or similar tools.



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  Experience with CDISC standards (SDTM, ADaM).



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  Strong data manipulation and visualization skills.

Education

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  Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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