Senior Statistical Programmer

Reference Number: 896116 - W
Type of placement: Permanent
Location: Switzerland, North West

Introduction:

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Senior Statistical Programmer on a permanent contract  based in Basel area.

 The ideal candidate should have 5+  years of previous experience in statistical programming, of which at least 4 years within a pharmaceutical company or a clinical research organization.

 

Main Responsibilities:

  • Responsible for the implementation and use of programs to effectively analyze and report clinical trial data as the trial lead programmer;
  • Responsible for the review of trial documentation and providing feedback from statistical programming perspective, as well as study set-up in the reporting environment;
  • Responsible for the definition of project and trial analysis data sets and metadata;
  • In agreement with the lead statistical programmer and/or statistician, designs and implements trial and project analysis data sets and metadata including complex data derivations, data mapping and data pooling;
  • Informs and suggests solutions to the lead statistical programmer and/or statistician on critical issues within the project;
  • Develops programs and generates tables, listings and figures for trial or project specific reports and statistical analyses in agreement with trial documentation and guidelines from the principal statistical programmer and/or the statistician;
  • Performs and documents quality control (QC) activities as per company standard operating procedures (SOPs), working practices, and guidance from the lead statistical programmer.

Qualifications and Experience:

  • University degree (or equivalent) preferably in mathematics, informatics or other scientific discipline;
  • Advanced knowledge of programming in SAS and of statistical analyses in clinical trials;
  • 5+ years experience in statistical programming, of which at least 4 years within a pharmaceutical company or a clinical research organization (CRO).
  • Experience in the review of Statistical Analysis Plans, study set-up and review of study specific documents, e.g. Clinical Protocol, CRF, annotated CRF, data validation guidelines;
  • Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management;
  • Good knowledge and understanding of CDISC, especially SDTM and ADaM;
  • Basic knowledge of R, knowledge of other programming languages and of data management principles and tools is an asset;
  • Ability to work independently, analyze problems and formulate ideas in a structured and logical manner;
  • Knowledge of international clinical research regulations and requirements (ICH-GCP);
  • Excellent interpersonal and communication skills;
  • Fluent in English (written and spoken);
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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