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 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.
* 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.
* 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 Reviewers 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.
Learn more about our EEO & Accommodations request here.
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