Contract Statistician – Biotech – Ticino, Switzerland
AL Solutions are looking to find a Contract Statistician to work for a small, privately-owned, Biotech company in the Italian region of Switzerland. You can have some remote-flexibility, but must be office based at least 50%.
This is an opportunity to join an Oncology focused organisation that has been privately owned for 40 years. We are now looking for a new Senior Statistician to join them, with strong knowledge across the clinical development process, in order to lead their studies.
- 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)
- 5+ years’ experience within the Pharmaceutical industry as a Statistician and knowledge of Data Management
- Strong SAS skills
- CDISC knowledge
- Willingness to travel
- Ability to oversee and manage CROs/external vendors
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/Europe for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, then please visit our website for a list of more vacancies – www.al2s3.com
To apply/find out more please reach out via: