Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company 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 Senior Statistician provides expert statistical input to the design and analysis of clinical studies and development plans. 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 expert 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 project teams and provide statistical support and solutions.
- Participate in interactions with health Authorities.
- Provide mentoring and support to other statisticians.
- 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 6 years' experience as project/study statistician in Clinical Development in the pharmaceutical industry
- Strong statistical methodology knowledge and applications. Experience using Bayesian designs is a plus
- Good programming skill in SAS. Experience using R is a plus
- Up to date knowledge of regulatory requirements related to statistics
- Good communication skills and ability to build positive relationships
- Display excellent planning, organization and communications skills
- Ability to effectively work and collaborate in a complex matrix organization
- 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 using this form.
For more information : www.debiopharm.com