Senior Statistical Programmer

vor 10 Stunden

Basel, Schweiz CTC Resourcing Solutions Vollzeit

Senior Statistical Programmer – 6300 ASH

Our client, headquartered in Switzerland – a biotech hub of Europe – is a high-potential biopharmaceutical company specialized in the discovery, development, and commercialization of innovative small molecules. They are looking for a Senior Statistical Programmer for an initial 12-month contract based in the 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, 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.
  • Complies with ICH-GCP regulations and company SOPs.
  • Contributes to and leads initiatives and non-clinical projects.

Qualifications and Experience:

  • Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
  • University degree (or equivalent) preferably in mathematics, informatics, or another scientific discipline.
  • At least four years of experience in statistical programming, of which at least three within a pharmaceutical company or a clinical research organization (CRO).
  • 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.
  • 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.
  • Fluent in written and spoken English.
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