at ICON Strategic Solutions in Augusta, Maine, United States
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Pharmacometrics (PM) Support Programmer provides support to the global Pharmacometrics modelling team within Clinical Pharmacology & Pharmacometrics in delivering high quality PK/PD NONMEM datasets. Services also include quality control of the NONMEM datasets, and QC of customized R packages created for the department. Datasets are created both before (unclean data) and after database lock. This function liaises closely with Data Management, Statistical Programming, and bio-analytical teams. Services are delivered by applying efficient R programming skills and knowledge of basic PK/PD concepts.
+ Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
+ Clear communication with partnering departments: Data Management, Statistics, Statistical Programming and Bio-analytical providers.
+ Ensures quality NONMEM input data (accurate, valid and complete) is provided to the Pharmacometrics Leaders within projected timelines for low to medium complexity projects.
+ Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
+ Programming and QC of NONMEM PK/PD datasets based on SDTM/ADAM datasets.
+ Follow up and QC of outsourced NONMEM datasets.
+ Prepare submission projects per internal PM guideline.
+ QC of existing, customized R packages used for standardization of Pharmacometric works (build testing suite of customized packages).
+ Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables.
+ Critically reviews requirements and data, identifies gaps, suggests solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Involved as active driver in development of new PM standardization efforts.
Minimum degree: BA/BS
+ Degree in a health or science related field. IT degree can also be considered if working knowledge with R software.
+ Min. 4 years industry experience.
+ Strong working knowledge of R software (important)
+ Interest in PK/PD and clinical trial concepts.
+ Studious and data driven person. Eye for detail is very important.
+ Proficient in speaking and writing in English. Effective communication skills, oral and written.
+ Knowledge of SDTM, ADAM and controlled terminology concepts.
+ Knowledge op PK/PD principles
+ Previous experience in applying standardization efforts for NONMEM file creation submission, and QC.
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.