PK/PD Statistical Programmer (m/w/d) - homebased
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 high‑quality, compliant datasets for modeling and analysis, ensuring accuracy from early (unclean) through post‑lock clinical data. The ideal candidate brings deep technical expertise, strong problem‑solving skills, and a solid understanding of PK/PD principles.
Key Responsibilities
Program, validate, and deliver NONMEM‑ready PK/PD datasets based on SDTM/ADaM standards using advanced R programming skills.
Create high‑quality PK/PD datasets for both pre‑lock and post‑lock 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 cross‑functional 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
Bachelor's or Master's 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.
Expert‑level proficiency in R for data processing, dataset creation, and QC automation.
Hands‑on 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, cross‑functional 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 real‑world settings.
EEO Minorities/Females/Protected Veterans/Disabled
Pharmacovigilance Data Analysis Manager
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high‑quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes.
What your responsibilities will be
Lead and coordinate safety data analysis for aggregate reports preparation, signal management, and ad hoc requests.
Support drug safety systems through business administration tasks, including database configuration updates, submission rules management, and testing with regulatory authorities.
Serve as a subject matter expert in delivering and evaluating cost‑effective, sustainable solutions that meet business requirements.
Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/technical specifications, and process flow diagrams.
Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
Act as the primary PV contact for IT‑related PV projects.
Drive innovation through AI in pharmacovigilance: stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations.
Who you are
You have a bachelor's degree in Health Sciences, Bioscience, or related field; additional training or experience in bioinformatics/biostatistics or data analysis tools such as R or Power BI.
You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance databases.
You have proven knowledge of Good Pharmacovigilance Practices, existing legislation, regulations, guidelines, medical coding, and safety‑data administration.
You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
Familiarity with reporting tools such as Business Objects is strongly preferred.
You have knowledge of E2B (R2) and E2B (R3) and familiarity with medical terminology, MedDRA, WHO Drug.
You speak fluent Spanish and English.
You are a proven self‑starter with strong work ethic and the ability to exercise good judgment.
You must be proactive, results‑oriented and have strong attention to detail.
Strong organizational, analytical and problem‑solving skills with the ability to make structured decisions on a routine basis.
Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
Ability to effectively prioritize and manage multiple tasks to ensure successful completion of targeted deadlines.
What we offer
We are committed to maintaining an atmosphere that encourages all employees to develop their professional careers in an excellent working environment.
EEO Statement
Grifols is an equal opportunity employer.
Benefits & Contract
Contract of Employment: Permanent position.
Flexibility for U Program: Hybrid.
Location: Sant Cugat del Vallès (preferably); Other locations such as Los Angeles, Clayton or Dublin may be considered.
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