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Urgent! Senior Statistical Programmer (Contract) Position in España - ePharmIT

Senior Statistical Programmer (Contract)



Job description

Senior Statistical Programmer (Contract) Direct message the job poster from ePharmIT Our client is a global pharmaceutical brand who are expanding their programming and statistical teams.

They are currently looking for senior level programmers who will be engaged on inital 12 month contracts on a fully remote basis.

Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintain the Analysis and Reporting production tools and the information infrastructure.

Key responsibilities Collaborate with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project.

Data submission strategy (e.g., managing legacy data, pooling data) Oncology experience essential, preferably study lead experience Responses to regulatory agency queries Tables Figures and Listings (TFLs) Development Safety Update Reports (DSURs) Periodic Benefit-Risk Evaluation Reports (PBRERs) Office of Scientific Investigations (OSI) data sets and listings Regulatory and/or Payer submission related analysis data sets and/or TFLs Associated quality and process documentation as per applicable business processes Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets Pharmacokinetics/pharmacodynamics data preparation and analysis Manipulating and analyzing adjudicated data Data preparation and analysis for Global Medical Affairs work Timely upload of documents to eTMF Key qualifications BSc in mathematics, statistics, engineering, computer science, or life or social sciences.

Advanced SAS programming knowledge and experience.

Knowledge of database set-up and report publishing requirements.

Advanced knowledge of technical and regulatory requirements related to the role.

Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.

Advanced knowledge and experience of clinical drug development or healthcare.

Seniority level Mid-Senior level Employment type Contract Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing and Research Services J-18808-Ljbffr


Required Skill Profession

It / Computing / Software



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