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As a Principal Statistical Programmer, you will manage statistical programming tasks in clinical trials, ensuring high-quality data reporting and compliance with regulations.
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Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
Position Overview:
This position reports to the Engagement lead in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on mainly oncology therapeutic area. A majority of the programmer’s work is hands-on statistical programming and should be keeping the track of the study deliverables for high quality deliverables in time. This position is responsible for keeping all documents updated, assignments of the tasks. Work is to be performed in a team environment, where team members may be distributed globally.
As a Principal Statistical Programmer, your responsibilities will include:
- Meetings and communications
- Generate SDTM and ADaM specifications
- Generate & QC assigned dataset domains
- Support submission activities
- Generate TLFs (patient profile, interim analysis, annual summary report, final CSR)
- Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s)
- Handling Data transfers to sponsor (or other designee)
- Publication support
- Ad hoc tasks/activities requested by sponsor
- Writing SAS macros and other utilities and tools
- Reviewing documents/specifications/output created by sponsor’s Partner CROs
- Maintenance of associated tracking and validation documentation
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
- 8+ years of experience as a Statistical Programmer in clinical Development environment
- Excellent SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
- Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
- Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
- Prior working experience with Oncology studies
- Must be able to work independently
- Outstanding communication skills (written and verbal) and strong leadership skills
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