We are seeking an experienced PK/PD Statistical Programmer with strong experience in R programming PK/PD datasets and NONMEM dataset creation. This role supports Pharmacometrics by producing highquality compliant datasets for modeling and analysis ensuring accuracy from early (unclean) through postlock clinical data. The ideal candidate brings deep technical expertise strong problemsolving skills and a solid understanding of PK/PD principles.
Key Responsibilities
- Program validate and deliver NONMEMready PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills.
- Create highquality PK/PD datasets for both prelock and postlock clinical data.
- Independently execute programming tasks of medium to high complexity with excellent accuracy and timeliness.
- Critically review data identify inconsistencies or gaps and propose solutions to improve dataset quality and programming efficiency.
- Perform quality control (QC) of NONMEM datasets including those produced by external partners.
- Support preparation of deliverables for regulatory submissions following internal Pharmacometrics guidelines.
- Conduct QC of customized R packages used for pharmacometrics workflows; enhance or build automated test suites where needed.
- Liaise with crossfunctional teams including Data Management Biostatistics Statistical Programming and Bioanalytical groups to resolve data issues and ensure alignment.
- Adhere to relevant SOPs working instructions and regulatory standards; maintain inspection readiness.
- Contribute as a technical driver in the development and improvement of new PM standardization initiatives related to dataset creation and QC.
Required Qualifications
- Bachelors or Masters degree in a health science IT mathematics or related field.
- Minimum 6 years of industry experience in clinical data analysis statistical programming or pharmacometrics support.
- Expertlevel proficiency in R for data processing dataset creation and QC automation.
- Handson experience creating NONMEM datasets including complex data structures for PK/PD analyses.
- Strong understanding of SDTM ADaM and controlled terminology.
- Applied knowledge of PK/PD principles and clinical trial concepts.
- High attention to detail with strong analytical documentation and communication skills.
- Ability to work independently and collaboratively across global crossfunctional teams.
Preferred Skills
- Experience building or enhancing standardized workflows for NONMEM dataset creation submission packages and QC.
- Experience with R package testing validation frameworks or reproducible programming practices.
- Familiarity with pharmacometrics workflows in clinical or realworld settings.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
IC
We are seeking an experienced PK/PD Statistical Programmer with strong experience in R programming PK/PD datasets and NONMEM dataset creation. This role supports Pharmacometrics by producing highquality compliant datasets for modeling and analysis ensuring accuracy from early (unclean) through post...
We are seeking an experienced PK/PD Statistical Programmer with strong experience in R programming PK/PD datasets and NONMEM dataset creation. This role supports Pharmacometrics by producing highquality compliant datasets for modeling and analysis ensuring accuracy from early (unclean) through postlock clinical data. The ideal candidate brings deep technical expertise strong problemsolving skills and a solid understanding of PK/PD principles.
Key Responsibilities
- Program validate and deliver NONMEMready PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills.
- Create highquality PK/PD datasets for both prelock and postlock clinical data.
- Independently execute programming tasks of medium to high complexity with excellent accuracy and timeliness.
- Critically review data identify inconsistencies or gaps and propose solutions to improve dataset quality and programming efficiency.
- Perform quality control (QC) of NONMEM datasets including those produced by external partners.
- Support preparation of deliverables for regulatory submissions following internal Pharmacometrics guidelines.
- Conduct QC of customized R packages used for pharmacometrics workflows; enhance or build automated test suites where needed.
- Liaise with crossfunctional teams including Data Management Biostatistics Statistical Programming and Bioanalytical groups to resolve data issues and ensure alignment.
- Adhere to relevant SOPs working instructions and regulatory standards; maintain inspection readiness.
- Contribute as a technical driver in the development and improvement of new PM standardization initiatives related to dataset creation and QC.
Required Qualifications
- Bachelors or Masters degree in a health science IT mathematics or related field.
- Minimum 6 years of industry experience in clinical data analysis statistical programming or pharmacometrics support.
- Expertlevel proficiency in R for data processing dataset creation and QC automation.
- Handson experience creating NONMEM datasets including complex data structures for PK/PD analyses.
- Strong understanding of SDTM ADaM and controlled terminology.
- Applied knowledge of PK/PD principles and clinical trial concepts.
- High attention to detail with strong analytical documentation and communication skills.
- Ability to work independently and collaboratively across global crossfunctional teams.
Preferred Skills
- Experience building or enhancing standardized workflows for NONMEM dataset creation submission packages and QC.
- Experience with R package testing validation frameworks or reproducible programming practices.
- Familiarity with pharmacometrics workflows in clinical or realworld settings.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
IC
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