Principal Statistical Programmer

Basel Area - Allschwil, BL, CH

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.

Job Responsibilities

• Accountable for all statistical programming activities


• Coordinate and supervise the activities of the Statistical Programmers by setting clear expectations and objectives; assign tasks, set priorities, provide technical help to ensure timely and efficient completion of projects


• Support and participate in the development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, exploratory analyses (as required); i.e.: provide statistical programming support to generate ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses


• Supervise vendor selection process for outsourced statistical programming work, keep track of statistical programming activities done by selected vendors and ensure regular feedback is provided


• Program ADaMs, tables, figures, and listings (TFLs) according to approved specifications, and negotiate programming timelines


• Lead statistical programming activities and act as Trial Statistical Programmer  


• Drive the implementation of computerized systems and tools to support the trials/projects data analysis, data flow, including the handling of organizational aspects


• Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as CDISC requirements (ADaM, eCTD, Define.xml), and ensure standards for documents, metadata, data and statistical reports are created, maintained and applied

Candidate’s Requirements

• University degree (or equivalent) preferably in mathematics, informatics or other scientific discipline


• Excellent knowledge of programming in SAS and of statistical analyses in clinical trials


• 7+ years’ experience in provision of programming support for clinical trial management and reporting, or equivalent experience


• Excellent organizational, time management and project management skills with team leadership experience, as demonstrated by ability to organize and motivate highly qualified professionals, and the ability to delegate and prioritize work to meet project timelines


• Advanced knowledge and understanding of CDISC, especially SDTM and ADaM


• Knowledge of international clinical research regulations and requirements (ICH-GCP) and 21 CFR Part 11


• Experience in the review of Statistical Analysis Plans, study set-up and review of study specific documents, e.g. Clinical Protocol, CRF, annotated CRF, data validation guidelines


• Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management


• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan)


• Excellent problems’ solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possible.


• Fluent in English

What Idorsia offers

• Exciting opportunities  for development and professional growth within our dynamic organization


• A collaborative and solution oriented enviroment where you can make a difference


• An innovative and open culture in a truly multicultural environment


• A competitive salary and generous social benefits

Work  Location: Allschwil

Country: Switzerland

Business Area: Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1026

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.