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 want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, 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 1,000 highly qualified specialists dedicated to realizing our ambitious targets.
- Responsible for all biostatistical aspects of the project and/or trial, the statistician is assigned to.
- Interacts with authorities statisticians to set and/or defend decisions on statistical issues for the project, the statistician is assigned to.
- Plans details of the randomization schedule with the appropriate members of the project team.
- Reviews and approves protocol and CRF (and their amendments) prior to their use or submission to approval committees.
- Verifies the appropriateness of the planned analysis and writes or supervises the writing of the trial statistical analysis plan.
- Performs or supervises statistical analyses and discusses the results and the presentation of the results with appropriate team members.
- Writes or supports the writing of the statistical section/module of reports (CSR, integrated safety/efficacy reports and publications). Reviews and approves the reports.
- Verifies adherence to statistical standards and SOPs within the project.
- Ensures appropriate statistical planning, analysis and reporting of one or more assigned clinical studies, development programs or drug submission dossier.
- Reviews and anticipates resource requirements for existing projects.
- Maintains / develops a high standard of statistical methodology.
- University degree (or equivalent) in mathematics, statistics or related disciplines.
- In depth knowledge and expertise in statistics and its applications to clinical trials.
- Good knowledge of statistical software (at least SAS®) and of data management principles and tools.
- At least five years' experience as statistician in clinical development within the pharmaceutical industry or clinical research organizations.
- Knowledge of international clinical research regulations and requirements.
- Ability to work efficiently in an international team environment.
- Excellent interpersonal, communication and management/coaching skills.
- Must be able to work according to timelines and achieve project deadlines.
- Fluent in English
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.