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Clinical research: Opportunities at SGS

Clinical research: Opportunities at SGS

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We are recruiting for our International Project Management team in our Belgian offices and are currently seeking to hire a Clinical Project Manager...

014772 Requisition #

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SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 86.000 people and operates a network of more than 1000 offices and laboratories around the world. One of the business segments, Clinical research, is a leading Contract Research Organization (CRO) providing drug development and post-approval services to the pharmaceutical and biopharmaceutical industry. It’s Biostatistics department is strongly expanding and therefore looking for several new colleagues in the position of : Senior Statistical Programmers - Candidates can work office based in Belgium (Mechelen) or home based in Spain, Germany, the UK, the Netherlands In this position you will be responsible for the generation and communication of the statistical results for multiple clinical research projects in a wide variety of therapeutic areas. Able to work independently and collaboratively, your primary responsibilities will include: • Participate in building the design of a clinical trial phase I protocol • Write and review the statistical analysis plan for phase I trials • Develop Table Shells and specifications on CDISC ADaM datasets • Program and validate the statistical analysis, possibly in co-operation with other Biostatisticians and/or Statistical Programmers • Communicate to the Data Manager on database topics to guarantee reliable conclusions • Create high-quality graphs for visualization of data and analytic results • Work in close collaboration with the Biostatistical Coordinator and other colleagues

017861 Requisition #

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We would like to inform you that we are currently looking for (m/f) : BIOSTATISTICIANS - Creation of the Statistical Analysis Plan - Development of analysis datasets (CDISC ADaM format) via SAS programming - Development of analysis tables, listings and figures via SAS programming - Implementation of statistical methodology - Quality control of project deliverables - Review and/or provide input in the study protocol (sample size calculations), CRF and clinical study report BIOSTATISTICAL ANALYSTS - Development of analysis datasets (CDISC ADaM format) via SAS programming - Development of analysis tables, listings and figures via SAS programming - Implementation of CDISC standards in clinical trials - Quality control of project deliverables - Creation of the Statistical Analysis Plan and mock TLFs for Phase I studies - Production and optimization of system tools and macros

014806 Requisition #

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In the spirit of continued growth and to help improve our business, we are seeking candidates for the following position (m/f): Application developer (Mechelen) Function: • You evaluate the need for new applications and create corresponding user requirements. • You design and develop applications in C# using a back-end Oracle database • You work closely with the end-users • You produce the necessary test plans • You document all modifications, enhancements and analyses • You create the necessary user guidelines to support the end user in using the application

014330 Requisition #

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SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 86.000 people and operates a network of more than 1000 offices and laboratories around the world. One of the business segments, Clinical research, is a leading Contract Research Organization (CRO) providing drug development and post-approval services to the pharmaceutical and biopharmaceutical industry. It’s Biostatistics department is strongly expanding and therefore looking for several new colleagues in the position of : Senior Biostatisticians – Candidates can work office based in Belgium (Mechelen) or home based in Spain, Germany, the UK, the Netherlands In this position you will be responsible for the generation, validation and communication of the statistical results for multiple clinical research projects in a wide variety of therapeutic areas. Able to work independently and collaboratively, your primary responsibilities will include: • Participate in building the design of a clinical trial protocol, with inclusion of sample size calculation • Write and review the statistical analysis plan for phase I to IV trials • Develop Table Shells and specifications on CDISC ADaM datasets • Program and validate the statistical analysis, possibly in co-operation with other Biostatisticians and/or Statistical Programmers • Pay special attention to the inferential statistics with inclusion of thorough quality control by double programming • Communicate to the Data Manager on database topics to guarantee reliable conclusions • Create high-quality graphs for visualization of data and analytic results • Review the Clinical Study Report and support the Medical Writer in the interpretation of the statistical results • Work in close collaboration with the Biostatistical Coordinator and other colleagues

017860 Requisition #

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SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 86.000 people and operates a network of more than 1000 offices and laboratories around the world. One of the business segments, Clinical research, is a leading Contract Research Organization (CRO) providing drug development and post-approval services to the pharmaceutical and biopharmaceutical industry. It’s Biostatistics department is strongly expanding and therefore looking for several new colleagues in the position of : Senior Biostatisticians – Candidates can work office based in Belgium (Mechelen) or home based in Spain, Germany, the UK, the Netherlands In this position you will be responsible for the generation, validation and communication of the statistical results for multiple clinical research projects in a wide variety of therapeutic areas. Able to work independently and collaboratively, your primary responsibilities will include: • Participate in building the design of a clinical trial protocol, with inclusion of sample size calculation • Write and review the statistical analysis plan for phase I to IV trials • Develop Table Shells and specifications on CDISC ADaM datasets • Program and validate the statistical analysis, possibly in co-operation with other Biostatisticians and/or Statistical Programmers • Pay special attention to the inferential statistics with inclusion of thorough quality control by double programming • Communicate to the Data Manager on database topics to guarantee reliable conclusions • Create high-quality graphs for visualization of data and analytic results • Review the Clinical Study Report and support the Medical Writer in the interpretation of the statistical results • Work in close collaboration with the Biostatistical Coordinator and other colleagues

017709 Requisition #

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SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 86.000 people and operates a network of more than 1000 offices and laboratories around the world. One of the business segments, Clinical research, is a leading Contract Research Organization (CRO) providing drug development and post-approval services to the pharmaceutical and biopharmaceutical industry. It’s Biostatistics department is strongly expanding and therefore looking for several new colleagues in the position of Senior Statistical Programmer Candidates can work office based in Belgium (Mechelen) OR home based in Spain, Germany, the UK, the Netherlands In this position you will be responsible for the generation and communication of the statistical results for multiple clinical research projects in a wide variety of therapeutic areas. Able to work independently and collaboratively, your primary responsibilities will include: • Participate in building the design of a clinical trial phase I protocol • Write and review the statistical analysis plan for phase I trials • Develop Table Shells and specifications on CDISC ADaM datasets • Program and validate the statistical analysis, possibly in co-operation with other Biostatisticians and/or Statistical Programmers • Communicate to the Data Manager on database topics to guarantee reliable conclusions • Create high-quality graphs for visualization of data and analytic results • Work in close collaboration with the Biostatistical Coordinator and other colleagues

017708 Requisition #

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For the moment we are looking for a (m/f) : Clinical Data Manager - SGS Life Science Services (Mechelen) Tasks : Data cleaning of clinical subject database which means:  Review of case report forms  Defining the cleaning package of a clinical trial  Check clinical database on inconsistent, missing and incorrect data  Coding of medications and medical events  Generate queries towards the sites in order to get the data clean  Communications with all involved parties  Overall responsibility to deliver a clean clinical database to the statisticians  …

016587 Requisition #

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For the moment we are looking for a (m/f) : Junior Master Biomedical Sciences for Clinical Data Manager - SGS Life Science Services (Mechelen) Tasks : Data cleaning of clinical subject database which means:  Review of case report forms  Defining the cleaning package of a clinical trial  Check clinical database on inconsistent, missing and incorrect data  Coding of medications and medical events  Generate queries towards the sites in order to get the data clean  Communications with all involved parties  Overall responsibility to deliver a clean clinical database to the statisticians  …

010790 Requisition #

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In the spirit of continued growth and to help improve our business, we are seeking candidates for the following position (m/f): Clinical Report Designer - SGS Life Science Services (Antwerpen) Tasks : The main task of the Report Designer consists of designing of the CRF based on a clinical trial protocol and the sponsor’s specifications and reports to facilitate the data review. The Report Designer is also responsible for the thorough follow-up of the CRF during the further conduct of the trial (need for amendments). CREATING Sample CRF :  Generate an Sample CRF based on the LabPas Set-up and predefined specifications  Ensure review of the Sample CRF by other parties (internal and external) until finalization  Implement changes to the Sample CRF when needed  Make sure the sample CRF and Subject CRF are created / updated simultaneously. CREATING Subjects CRF :  Generate test data based on the LabPas Set-up and predefined specifications  Generate an CRF based on the LabPas Set-up, predefined specifications and test data  Update Subject CRF based on updates made in the sample CRF  Thorough review of the subject CRF upon first creation CREATING Review Reports / Metrics:  Generate ADHOC reports on request  Design new reports for Sponsors and/or Internal staff members  Review designed reports + validate.  Maintain and update existing reports on a regular base.

012439 Requisition #

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