Padmi

PK/PD Statistical Programmer (m/w/d) - homebased

IndiaPosted 2 months ago
Data Science And StatisticsMid-levelFull Time; Regular
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We are seeking an reputed company 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 NONMEMreputed company PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills. Create highquality PK/PD datasets for both reputed companylock and postlock clinical data. Independently execute programming tasks of reputed company 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. reputed company 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 reputed company to resolve data issues and ensure alignment. Adhere to relevant SOPs, working instructions, and regulatory standards; maintain inspection readiness. Contribute as a technical reputed company in the development and improvement of new PM standardization initiatives reputed company to dataset creation and QC. Required Qualifications Bachelors or Masters degree in a health, science, IT, mathematics, or reputed company 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 reputed company 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 reputed companyworld settings. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company 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 reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. Apply To This Job We are seeking an reputed company 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 NONMEMreputed company PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills. Create highquality PK/PD datasets for both reputed companylock and postlock clinical data. Independently execute programming tasks of reputed company 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. reputed company 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 cus

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