Fortrea

As a Lead 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.

You can be 100% home-based in EMEA or, if you prefer, 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 datasets’ content (safety and efficacy) and endpoints.
• Previous Lead experience preferred.
• 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.

Learn more about our EEO & Accommodations request here.