Senior Statistical Programmer – 6300 ASH

 

Our client is 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, with the aim of transforming the horizon of therapeutic options is looking a Senior Statistical programmer for a initial 12 months contract with possibl extension 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 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 qre 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 5 years of experience in statistical programming 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