Senior Bio-statistician - Research focused company - ONCOLOGY
My client, a Swiss-headquartered biopharma company focused on drug development in oncology with a huge pipeline is looking for a Senior Bio-statistician. Take the next step in your career providing expert statistical input to the design and analysis of clinical studies and development plans.
This company distinguishes themselves from other companies as they have a big fund for research and development creating a steady flow of both incomes as new breakthroughs. Hence, you will not be bored or unchallenged in this very well established company.
As Senior Bio-statistician you are a key member of the clinical study team and you will; provide expert statistical input to the design and analysis of clinical studies and development plans; be accountable for the quality and timelines of all statistical and programming deliverables for assigned clinical studies, including studies outsourced to CRO partners; ensure timely availability of complete, accurate and consistent analysis results to support decision making. Your main tasks will be;
- 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.
What we are looking for in a candidate:
- 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.
If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!
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