Principal Statistical Programmer (Pk/Pd) (M/W/D)
Location
madrid, kingdom of spain
Job Type
Full-time
Category
IT
Posted
June 18, 2026
Key Responsibilities
Si los siguientes requisitos del puesto y la experiencia coinciden con sus habilidades, por favor, asegúrese de enviar su solicitud sin demora.
Lead the development and validation of CDISC‑compliant datasets (SDTM, ADaM) and Tables, Listings, and Figures (TLFs).
Design and implement PK, PK/PD, and safety ADaM datasets, ensuring compliance with industry standards and regulatory requirements.
Support Population PK (PopPK), PK/PD, and Exposure–Response (ER) analyses by developing and maintaining analysis‑ready datasets.
Collaborate closely with Clinical Pharmacology, Biostatistics, and Translational Medicine teams to support early‑phase decision‑making.
Provide programming leadership for Phase I / First‑in‑Human trials, crossover designs, and PK parameter pooling strategies.
Contribute to regulatory submissions, ensuring datasets and outputs meet global health authority standards (e.G., FDA, EMA).
Develop and maintain standard p...
Si los siguientes requisitos del puesto y la experiencia coinciden con sus habilidades, por favor, asegúrese de enviar su solicitud sin demora.
Lead the development and validation of CDISC‑compliant datasets (SDTM, ADaM) and Tables, Listings, and Figures (TLFs).
Design and implement PK, PK/PD, and safety ADaM datasets, ensuring compliance with industry standards and regulatory requirements.
Support Population PK (PopPK), PK/PD, and Exposure–Response (ER) analyses by developing and maintaining analysis‑ready datasets.
Collaborate closely with Clinical Pharmacology, Biostatistics, and Translational Medicine teams to support early‑phase decision‑making.
Provide programming leadership for Phase I / First‑in‑Human trials, crossover designs, and PK parameter pooling strategies.
Contribute to regulatory submissions, ensuring datasets and outputs meet global health authority standards (e.G., FDA, EMA).
Develop and maintain standard p...