Principal Statistical Programmer Sponsor Dedicated, EMEA

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 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.