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 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 your 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.
Complies with ICH-GCP regulations and company SOPs.
Contributes to and leads initiatives and non-clinical projects.
REQUIRED QUALIFICATIONS AND EXPERIENCE:
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 five years of experience in statistical programming, 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.
Apply:It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 113 742 in all correspondence.Senior Recruitment ConsultantT:E:
Expected salary:
Location: Schweiz
Job date: Sun, 19 Jan 2025 06:57:51 GMT
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