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Senior Recruitment Consultant l Life Sciences l Pharmaceuticals l Biotech l Medical Devices l Business Development
Senior Statistical Programmer - 6538
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 an initial 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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Information Technology and Science
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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