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Kuwait Jobs Today: Fortrea Company announces new job opportunities. Are you looking for job opportunities in Kuwait? Fortrea Company announces the opening of recruitment for many jobs in various specializations in Kuwaiton today’s date. These opportunities are available to all nationalities. Learn about the available jobs and how to apply through the following advertisement.
- Review SAPs and TFL shells from a programming perspective
- Advise 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 programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
- Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
- Respond to QA and client audits and support qualification audits
- Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business
- Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)
Your profile:
- Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
- In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming for clinical trials
- Solid professional experience as a statistical programmer within a biotech, CRO or pharmaceutical company
- Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
- Programming experience in R is required
- Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs
- Solid knowledge of CDISC standards
- Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
- A genuine work life balance
- Flexibility in working hours
- A thorough onboarding with support from your personal mentor
- A permanent employment contract with Fortrea
- Excellent training and career development opportunities, as well as support with advancing your individual education
- Strong support from your Line Manager and your team, as well as from more than 20,000 Fortrea colleagues worldwide
- Review SAPs and TFL shells from a programming perspective
- Advise 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 programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
- Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
- Respond to QA and client audits and support qualification audits
- Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business
- Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)
- Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
- Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs
- Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses
- Support/oversee submission activities (especially in late phase team)
- Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times
- Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes
Your profile:
- Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
- In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO or pharmaceutical company
- Solid experience with complex clinical trials (minimum 5 years) and the corresponding datasets’ content (safety and efficacy) and endpoints
- Ideally you will have knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
- Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs
- Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer’s Guides and submission standards
- An autonomous, collaborative work style, a curious mind and a keen attention to detail
- Review SAPs and TFL shells from a programming perspective
- Advise 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 programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
- Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
- Respond to QA and client audits and support qualification audits
- Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business
- Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)
- Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
- In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming for clinical trials
- Solid professional experience as a statistical programmer within a biotech, CRO or pharmaceutical company
- Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
- Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs
- Solid knowledge of CDISC standards
- Submission experience is ideal
- Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
- Business fluency in English – both spoken and written – is a must
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
- A genuine work life balance
- Flexibility in working hours
- A thorough onboarding with support from your personal mentor
- A permanent employment contract with Fortrea
- Excellent training and career development opportunities, as well as support with advancing your individual education
- Strong support from your Line Manager and your team, as well as from more than 20,000 Fortrea colleagues worldwide
- Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
- Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs
- Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses
- Support/oversee submission activities (especially in late phase team)
- Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times
- Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department standards and processes
- To go to the application page. (Job opportunities for Fortrea Company)
- Click on a 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.
- Job source: The official website of the company
- Posted Date: 24-6-2024 (Please check the date before applying).
- Required Nationalities: All nationalities.
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