Senior Statistical Programmer
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.
- 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.