STATISTICIAN AND DATA MANAGER
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology.
In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.
For our Clinical Research & Development department in Lugano we are looking for a:
STATISTICIAN AND DATA MANAGER
- Contribute to the strategic planning of product development with regard to the statistical/methodological input
- Contribute to the preparation of clinical study protocols
- Define and draw the SAP (Statistical Analysis Plan) in collaboration with the CRO
- Define the specification of Randomization list and participate in the activities defining the IWRS specification and testing its functionalities.
- Define the analysis datasets structure (ADaM)
- Review and cleaning of the data and definition of protocol violators and analysis populations
- Contribute to the Clinical Study Report
- Contribute in Regulatory Activities, such as scientific advice, NDA submission and FDA/EMA meetings.
- Contribute in the preparation of product document (Investigator Brochure), and of abstracts, posters and papers
- Coordinate and supervise the activities of defining the CRF (Case Report Form), Data Validation Plan, Data Management Plan (in collaboration with the CROs)
- Contribute in defining the raw data dataset structure (SDTM)
The successful candidate has the following qualifications:
- Minimum 5 years of operational experiences and technical expertise in the statistics and data management department of a pharmaceutical company or in a CRO
- Degree in Statistics or Mathematics
- Knowledge of English language is essential, so as the informatics tools
- Knowledge of SAS system is required
- Willingness to travel and also availability to travel outside the usual place of work, namely outside Company's headquarters
- Analytical skills, accuracy and synthesis
- Ability in team working
- Ability to interact with external consultants and CROs as well as with all other business functions
Helsinn Healthcare SA is offering attractive conditions, a pleasant working environment in a highly motivated team and a long-term perspective.
Please send relevant application with CV to: