Kuwait Jobs Today: Fortria Company announces new job opportunities Are you looking for job opportunities in Kuwait? Fortria Company announces the opening of applications for many jobs in different specializations in Kuwait today. These opportunities are available to all nationalities. Learn about the available jobs and how to apply through the following advertisement.
Jobs required at Fortria Company and their details:
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1- Statistical Programmer - Experience in SAS and R
Your responsibilities:
- Review of SAPs and TFL shells from a programming perspective
- Advising on the development of complex TFL shells from a programming perspective.
- Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
- Develop and maintain SAS software to create SDTM, ADaM, and TFLs datasets, and perform quality control for SDTM, ADaM, and TFLs
- Generate/define XML/PDF files, Analysis Results Metadata (ARM), aCRFs, and reviewer guides to support SDTMs and ADaMs
- Respond to quality assurance and customer audits and support qualification audits.
- Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming work.
- Maintain awareness of industry standards, global regulatory requirements, internal guidelines and standard operating procedures (SOPs).
personal file:
- A university degree in a related field such as mathematics, life sciences, statistics, computer science, etc.
- Alternatively: Completed equivalent professional training and/or equivalent professional experience in statistical programming for clinical trials
- Strong professional experience as a statistical programmer in a biotechnology company, contract research company, or pharmaceutical company
- Demonstrated knowledge of basic SAS, SAS macros, and SAS/STAT; demonstrated ability to debug SAS programs
- R programming experience required
- Proven professional experience with SDTMs, ADaM (safety and efficacy) datasets and TFLs
- Solid knowledge of CDISC standards
- Strong organizational skills, independent and collaborative working style, curious mind and keen attention to detail
2-Senior Statistical Programmer,
Main responsibilities:
- Plan, implement, and supervise all programming activities in the study, including but not limited to: estimating resources, working within budget, meeting timelines, maximizing quality, interacting with other departments, etc.
- Oversee the development of SDTM, ADaM and TLF, and conduct senior review of deliverables
- Liaise with other sponsor departments to meet additional programming needs, as needed to support publications, medical writing, development needs, and additional analytics.
- Support/supervise dispatch activities (especially in the late stage team)
- Ensure all activities are executed efficiently, with the necessary tools and macros properly prepared, and prioritizing quality at all times.
- Mentor less experienced team members in best practices regarding SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes
personal file:
- Ideally, a degree in a related field such as mathematics, life sciences, statistics, computer science, etc.
- Alternatively: Professional experience in statistical programming within clinical trials at a biotechnology, contract research, or pharmaceutical company
- Strong experience in complex clinical trials (minimum 5 years) and corresponding dataset content (safety and efficacy) and endpoints
- Ideally, you will have knowledge of all aspects of clinical trials, from initial study setup to study completion, with an understanding of the roles and responsibilities of all relevant disciplines, for example biostatistics and clinical data management.
- Expert knowledge of basic SAS, SAS macros, SAS/STAT, and debugging SAS programs
- Extensive knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, reviewer guides and submission standards
- Independent and collaborative working style, curious mind and strong attention to detail
3- Senior Statistical Programmer
Your responsibilities:
- Review of SAPs and TFL shells from a programming perspective
- Advising on the development of complex TFL shells from a programming perspective.
- Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
- Develop and maintain SAS software to create SDTM, ADaM, and TFLs datasets, and perform quality control for SDTM, ADaM, and TFLs
- Generate/define XML/PDF files, Analysis Results Metadata (ARM), aCRFs, and reviewer guides to support SDTMs and ADaMs
- Respond to quality assurance and customer audits and support qualification audits.
- Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming work.
- Maintain awareness of industry standards, global regulatory requirements, internal guidelines and standard operating procedures (SOPs).
4- Global Regulatory Submission Officer
Requirements (Experience, Education, Qualifications, Skills)
- Minimum 5-7 years of experience in pharmaceutical industry or drug development in regulatory affairs
- Excellent communication, organisation and planning skills with attention to detail.
- Extensive experience in leading clinical trial implementations at regional/global level
- Extensive experience in EU CTR application processes
- Direct project management skills and ability to work independently
- Understand and be able to identify the relevance of government processes and regulations as they relate to investigational drug regulations in particular.
- Bachelor's degree or higher
- mastering English language
5- Senior Statistical Programmer, Oncology
Your responsibilities:
- Review of SAPs and TFL shells from a programming perspective
- Advising on the development of complex TFL shells from a programming perspective.
- Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
- Develop and maintain SAS software to create SDTM, ADaM, and TFLs datasets, and perform quality control for SDTM, ADaM, and TFLs
- Generate/define XML/PDF files, Analysis Results Metadata (ARM), aCRFs, and reviewer guides to support SDTMs and ADaMs
- Respond to quality assurance and customer audits and support qualification audits.
- Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming work.
- Maintain awareness of industry standards, global regulatory requirements, internal guidelines and standard operating procedures (SOPs).
6- Leading statistical programmer
Main responsibilities:
- Plan, implement, and supervise all programming activities in the study, including but not limited to: estimating resources, working within budget, meeting timelines, maximizing quality, interacting with other departments, etc.
- Oversee the development of SDTM, ADaM and TLF, and conduct senior review of deliverables
- Liaise with other sponsor departments to meet additional programming needs, as needed to support publications, medical writing, development needs, and additional analytics.
- Support/supervise dispatch activities (especially in the late stage team)
- Ensure all activities are executed efficiently, with the necessary tools and macros properly prepared, and prioritizing quality at all times.
- Mentor less experienced team members in best practices regarding SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes
How to apply for jobs
To apply for the above mentioned jobs, you can follow these steps:
- To go to the application page ( job opportunities for Fortria Company )
- Click on the job title to view details.
- Please click the "Easy Apply" button at the top of the page.
- Enter the required information in the pop-up screens.
- Click Review to review the form.
Source and additional details
- Job source: Company's official website
- Publication date: 4-8-2024 (Please check the date before applying).
- Required nationalities: All nationalities.
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