A global swiss pharmaceutical organisation is looking for a Senior Biostatistician to provide expert statistical input to the design and analysis of clinical studies and development plans. The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- Provide expert statistical support to Research and Development projects and teams.
- Serve as a study statistician in support of Phase I to Phase III trials.
- Provide input to the design, analysis and reporting for assigned projects and clinical trials.
- 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 recommendations and support to enable scientific and data driven decision making.
- May participate 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.
Skills and Requirements
- MSc. or PhD in Mathematical Statistics or related field.
- Minimum of 4 years' experience as a study statistician in Clinical Development in the pharmaceutical industry or CRO.
- Strong statistical methodology knowledge and applications. Experience using Bayesian designs is a plus
- Good programming skills in SAS and R.
- Up to date knowledge of regulatory requirements related to statistics.
- Good communication skills and ability to build positive relationships.
- Fluent in English.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.