As a Principal Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex projects for a renowned, innovative and global top pharmaceutical company.
You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics. It is a great opportunity to see more how this works from a Big Pharma perspective, whilst still being part of a global CRO with opportunity for future career growth.
This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas.
You can be 100% home-based in EMEA or you can work from our local office in your home country.
Your Responsibilities:
* 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 data sets 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.
* Fluency in English - both verbal and written - is a must.
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