Offer summary

Qualifications:

Degree in mathematics, life sciences, statistics, or computer sciences., Professional experience in statistical programming within clinical trials, ideally over 5 years., Expert knowledge of SAS programming, including macros and statistical procedures., Broad understanding of clinical trial processes and CDISC standards..

Key responsibilities:

Plan, execute, and oversee programming activities for clinical studies.

Liaise with various departments to support publications and analyses.

Support and oversee submission activities, especially in late-phase trials.

Mentor junior team members and ensure quality and efficiency in programming tasks.

Job description

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. Our sponsor is looking for Principal Statistical Programmers capable of overseeing studies from the Pharma side.

You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety and Biometrics. This may be for either/or in-house programmed or out-sourced studies in either their Early or Late Phase team. 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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