A clinical stage biopharmaceutical company is advertising a vacancy for a Statistical Programmer, 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. The Statistical Programmer will support the biostatistician and the project team for diverse statistical/programming tasks.
- Providing relevant input in the development of the CRF, statistical analysis plan, and mock tables, listings, and figures.
- Critically reviewing derived datasets specifications and derived datasets (ADaM).
- Developing programs to perform QC of statistical outputs.
- Defining program specific standards for ADaM datasets.
- Checking compliance of CRO delivered ADaM datasets to CDISC standards.
- Verifying define.xml (for ADaM's).
- Developing, validating, and documenting programs for additional post-hoc analyses.
- Developing, reviewing, documenting, and performing validation of generic SAS macros, and creating a macro library.
- Participating in project team meetings.
- Supporting data submission activities according to regulatory guidelines (e.g. ISS, ISE).
- Supporting outsourcing programming activities and overseeing the QC of these activities.
Skills and Requirements:
- Bachelors or higher degree in Science, Statistics, or Information Technology, or equivalent combination of education and related work experience.
- Minimum of 3-4 years of professional experience desired.
- Thorough knowledge of and experience with CDISC standards is desired.
- Demonstrable ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE).
- Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development.
- Excellent knowledge of SAS is a must.
- Knowledge in R is a plus.
- Experience in managing CROs and vendors is a plus.
- Biotech experience is a plus.
- Demonstrable 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.
Up to £65000.00 per annum
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