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 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 resource estimation, working within budget, meeting timelines, and maximizing quality interaction with other departments.
* Oversee SDTM, ADaM, and TLF development and 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 SDTM, ADaM, 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 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 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.
Key Skills
* Business Development
* Customer Service
* Attorney
* CISSP
* Data Analysis
Learn more about our EEO & Accommodations request here.
Employment Type: Full-Time
Experience: years
Vacancy: 1
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