Senior Statistical Programmer

Job content

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated Senior Statistical Programmerto join our team !

Job 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 project 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, data flow, including the handling of organizational aspects.
• Complies with ICH-GCP regulations and company SOPs.
  

Candidate’s Requirements

• University degree (or equivalent) preferably in mathematics, informatics or other 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 commitment to achieve common goals
  

What Idorsia Offers

• Exciting opportunities for development and professional growth within our dynamic organization
• A collaborative and solution-oriented environment where you can make a difference
• An innovative and open culture in a truly multicultural environment
• A competitive salary and generous benefits
  

Work Location: Allschwil- Basel Area

Country: Switzerland

Business Area: Global Clinical Development - Biometry

Schedule: Fulltime

Job Type: Permanent

Job ID: 2286

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.