We are looking for an ambitious Senior Statistical Programmer to join our business partner international team (Europe, US) that prides itself on helping people in the life sciences make confident, data-driven decisions.
You will work directly with the stakeholders to lead and contribute to statistical programming projects and to ensure the statistical programming systems, processes, and deliverables are aligned with the relevant regulatory requirements. In this role, you will monitor quality, timelines, resource allocation, and productivity in relation to budgets and will ensure audit readiness for all tasks. You will provide mentoring and training to statistical programming staff members and may lead or contribute to the design of new statistical programming processes or the optimization of existing ones.
Our business partner is a global leading technology provider that offers complete Software Development, Web, Mobile Development, and IT Consulting, with highly diversified enterprise projects.
- You will lead programming activities and complex studies;
- Work on both internal and external projects;
- Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements (for instance: clinical study reporting, electronic records handling, and electronic submission of clinical data to agencies);
- Produce statistical analyses using SAS, CDSIC, SDTM, and ADaM;
- You will be responsible for implementing new techniques and tools;
- Maintain up-to-date knowledge of programming software (e.g., SAS, R, Python) as well as industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and training;
- You will be responsible for employing and ensuring correct standards and compliance with SOPs, and KPIs and managing CAPAs;
- Act as a mentor to members of the team on technical standards and data procedures.
- At least 6+ years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines;
- Experience as a lead statistical programmer on several concurrent projects;
- SAS statistical programming experience;
- Project management, organizational skills, ability to manage competing priorities, and flexibility to change;
- Good understanding of the drug development process, including knowledge of interfaces and interdependencies with other functions;
- Good time management and interpersonal skills;
- Written/verbal communication and presentation skills are needed along with the ability to establish and maintain effective working relationships with coworkers, managers, and clients;
- Excellent English communication skills, both verbal and written;
- BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics).
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