Statistician

**The company**:
Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and an innovative pipeline of cancer therapeutics.

Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners. Helsinn also has a fully integrated supply chain and product development through its subsidiary in Ireland, Helsinn Birex Pharmaceuticals Ltd.
**The role**

For their Statistics Department, the Company is looking for a Statistician to be based in Switzerland. The Statistician provides methodological and statistical support to projects in clinical development. He/she defines, plans, coordinates, and monitors all activities pertaining to the management and analysis of clinical data carried out internally and/or by third parties with the goal of the product registration and maintenance of post-licensure of the product.
**Key responsibilities**:

- Participate in the strategic planning of product development about the statistical/methodological input;
- Participate in the preparation of clinical study protocols;
- Request and approve the (mock) Randomization Lists;
- Coordinate and participate in the activities of defining ITR (Interactive Response Technology) and test its functionalities;
- Participate in the activities of Computer System integration and test its functionalities (e.g. IWRS and eCRF);
- Define and draw the SAP (Statistical Analysis Plan) in collaboration with the CRO;
- Participate in defining the analysis dataset’s structure (ADaM) in accordance with HHC Database Library and coordinating activities with CRO Statistician / Statistical Programmer;
- Review the data and participate in the definition of protocol violations and analysis population (Blind Data Review Meeting);
- Participate in preparing the Clinical Study Report;
- Participate in the preparation of documents for regulatory agencies (scientific advice, development safety report) and of product document (Investigator Brochure);
- Participate in Regulatory Activities, such as NDA submission and FDA/EMA meetings;
- Participate in preparation of abstracts, posters, and papers.
**Qualification & Professional Experience**
- Degree in Statistics or Mathematics;
- 5 to 15 years of operational experiences and technical expertise in the statistics and data management department of a pharmaceutical company or in a CRO;
- Previous experience with Oncology products is considered a plus;
- Technical skills in the statistics/pharmaceutical field and knowledge of the informatics tools;
- Knowledge of SAS system is required so as analytical skills, accuracy, and synthesis;
- Ability in team working and to interact with external consultants and CROs as well as with all other business functions;
- Fluent in English (spoken and written)

GR137