ePharmIT
Senior Statistical Programmer (Contract)
Job Location
UK, United Kingdom
Job Description
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 maintains the Analysis and Reporting production tools and the information infrastructure. Key requirements include: 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, including but not limited to the following: - 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 - Clinical Trial Transparency deliverables (data de-identification, results posting files) - Timely upload of documents to eTMF Essential experience/skills: • 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.
Location: UK, GB
Posted Date: 11/4/2025
Location: UK, GB
Posted Date: 11/4/2025
Contact Information
| Contact | Human Resources ePharmIT  | 
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