Associate Director, Expert Statistician

vor 1 Tag

Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

**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 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.

**Responsibilities**:
The Idorsia Biometry department is looking for an experienced statistician who can serve as a statistical lead on phase 2 and 3 clinical trials. In this role, she/he will be responsible for the statistical aspects of these trials:

- Responsible for all biostatistical aspects of the assigned project and/or trial
- Interacts to set and/or defend decisions on statistical issues for the assigned project/trial
- Informs and suggests solutions to line management on critical issues within the project
- Provide input into trial designs and objectives
- Write the statistical sections of the protocols, including the statistical methodology and sample size calculations
- Specify the randomization methods
- Write the statistical analysis plans, including the handling of missing data
- Adhere to SOPs and standards
- Keep timelines and resource estimates up to date
- Provide oversight of statistical tasks outsourced to external service providers
- Present the clinical trial results and contribute to clinical study reports
- Document statistical activities at study closure

We are looking for a statistician who is not only strong in statistics, but is also able to present the design and analysis aspects in our multidisciplinary clinical trial teams:

- University degree in statistics, mathematics or a related discipline
- At least 10 years of experience as statistician in clinical development within a pharmaceutical company, clinical/academic research organization or university medical statistics department.
- At least five years as Senior Statistician, (i.e., above Statistician level) in Clinical Development in
the Pharmaceutical Industry, or Clinical Research Organizations.
- Proven record of successfully managing external service providers
- Knowledge of international clinical research regulations and requirements
- Knowledge of statistical software (at least SAS®, preferably also R)
- Excellent interpersonal and communication skills
- Fluent in English

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