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.
Top Skills
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.
Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
