A clinical stage biopharmaceutical company is advertising a vacancy for a Senior Biostatistician, joining their team in Belgium. The organisation is known for their pipeline of differentiated antibody therapeutics, which has been utilised to build a clinical-stage portfolio of novel product candidates. This is an exciting opportunity to work with a company whose work is tailed from discovery through development to address patient needs.
- Serving as the responsible biostatistician on Phase I to III clinical trials. The trials can be relatively simple or complex.
- Contributing to clinical study synopses and protocols.
- Developing statistical analysis plans and/or performing senior review of statistical analysis plans.
- Reviewing statistical analyses of other statisticians and interpreting results from simple to complex clinical studies.
- Providing relevant input in the development and review of CRFs.
- Performing lead reviews and setting up internal QC of TFLs.
- Performing critical review of derived datasets specifications and derived datasets (ADaM).
- Contributing to clinical study reports.
- Reviewing simple to complex randomisation specifications and dummy randomization schemes.
- Participating in bid defence meetings.
- Participating in meetings with diverse regulatory authorities (FDA, EMA, PEI).
- Contributing to press releases and scientific papers.
Skills and Requirements:
- Master's degree in statistics or biostatistics required.
- Minimum of 6-8 years of biostatistical experience desired.
- Expertise in multiple statistical areas, the drug development process, SAS procedures, and good programming practices.
- Fluency with other statistical software such as R, EAST, Winbugs is a plus.
- Thorough knowledge of and experience with CDISC standards is desired.
- Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
- Experience in managing CROs and vendors is a plus.
- Biotech experience is a plus.
- Auto-immune and/or oncology clinical study background is a plus.
- multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Magenis at +44 203 854 1050 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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