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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 for a 12month contract based in Basel area.

 

Main Responsibilities:

• Responsible for the implementation and use of programs to effectively analyze and report clinical trial data as the trial programmer. 

• Responsible for the review of trial documentation and providing feedback from a 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 trial 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 trial 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 trial 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 trial programmer.

• Delivers listings, summary reports and figures to the trial programmer, the statistician and/or appropriate members of the clinical trial team as per the project timelines. 

• Maintains up-to-date documentation for the programs, metadata, data sets, tables, listings and figures that are under his/her responsibility and files all relevant trial documents in the eTMF. 

• Discusses data presentation methods with the trial programmer, statistician and/or appropriate members of the clinical trial team. 

• Informs and suggests solutions to the trial programmer, principal programmer and/or department head on critical programming issues within the department. 

• Performs the programming for standard and special analyses and provides the appropriate members of the clinical trial team with trial or project-specific listings, summary tabulations and graphics. 

• Provides technical advice and support to other colleagues. 

• Assesses, recommends and develops new standards, policies and procedures. 

• Supports the implementation of computerized systems and tools that facilitate the trials/projects data analysis, and data flow, including the handling of organizational aspects. 

• Comply with ICH-GCP regulations and company SOPs.

• Contributes to and leads initiatives and non-clinical projects.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required

• University degree (or equivalent) preferably in mathematics, informatics, or another scientific discipline. 

• Advanced knowledge of programming in SAS and of statistical analyses in clinical trials. 

• 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 analyze problems and formulate ideas in a structured and logical manner. 

• Must be able to work according to operating procedures, specifications and timelines. 

• At least four years of experience in statistical programming, of which at least three within a pharmaceutical company or a clinical research organization (CRO). 

• Ability to communicate effectively in English. 

• Knowledge of international clinical research regulations and requirements (ICH-GCP). 

• Excellent interpersonal and communication skills. 

• Ability to work independently with a commitment to achieve common goals.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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