Senior Statistical Programmer - 6300 ASH

Senior Statistical Programmer - 6300 ASH

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Direct message the job poster from CTC Resourcing Solutions AG

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. They are looking for a Senior Statistical Programmer for an initial 12 months contract (possible 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 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 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

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Information Technology, Science, and Research

Industries

• Biotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health Care