Debiopharm Group™ is a Swiss-based global biopharmaceutical group of five companies active in the development and manufacture of drugs and diagnostics tools. Debiopharm focuses on developing prescription drugs that target unmet medical needs. The group in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Biostatistics and Clinical Data Management team based in Lausanne we are looking for a
(100% - permanent contract)
The Statistician provides statistical support and input to the design and analysis of clinical studies. Is accountable for the quality and timelines of all statistical and programming deliverables for assigned clinical studies, including studies for which statistical activities are outsourced to CRO partners. He/she ensures timely availability of complete, accurate and consistent analysis results to support decision making. He/she is a key member of the clinical study team.
Your main responsibilities
- Provide statistical input to the design, analysis and interpretation of clinical studies
- Author statistical sections of protocols and statistical analysis plans
- Ensure provision of quality and timely statistical analyses results that support quality and timely decision making
- Lead statistical and programming study teams and perform statistical analyses
- Coordinate and provide statistical oversight for outsourced studies, ensuring CROs accountability for the quality of their deliverables
- Represent statistics within cross functional study teams and provide statistical support and solutions
- Assist with in interactions with health Authorities
- Maintain current scientific and regulatory knowledge
- Provide input/lead internal process improvement
- Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
- MSc. or PhD in statistics or related field
- Minimum of 4 years’ experience as project/study statistician in Clinical Development in the pharmaceutical industry or CRO
- Strong statistical methodology knowledge and applications. Experience using Bayesian designs is a plus
- Excellent programming skill in SAS. Experience using R is a plus
- Good experience using CDISC standards
- Up to date knowledge of regulatory requirements related to statistics
- Good communication skills and ability to build positive relationships
- Fluent in English
Debiopharm can offer you
- An international and highly dynamic environment, with a long term vision.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application
For more information : www.debiopharm.com