Who we are? Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide. THE ROLE We are currently looking for an enthusiastic and talented Biostatistician II, willing to be involved in all spectrums of activities. This role works cross-functionally with internal departments. This role is home-based in Romania. Key responsibilities Production of analysis and reporting deliverables (including statistical analysis plans) on behalf of and/or in conjunction with the Lead Biostatistician and HiRO clients. Creation and QC of study specifications for ADaM datasets, and statistical programming and QC of ADaM datasets for global Phase I-IV trials. Statistical programming and QC of tables, listings and figures for global Phase I-IV trial Qualifications and attributes Minimum of a Masters (M.Sc.) or equivalent in Medical Statistics or minimum of a degree (or equivalent) in Statistics/Mathematics. Minimum of 2 to 3 years of experience working for a CRO Fluent in spoken and written English. Good SAS programming skills. The ability to perform all duties as a project team member with minimal supervision. Computer literacy, ideally in one or more computing systems/programming languages/software packages in addition to SAS. Strong oral and written communication skills (including the ability to communicate statistical concepts and information to non-statisticians). Good understanding of medical terminology, clinical trial methodology, drug development process and ICH/GCP (especially relating to statistical methodology). Good knowledge of statistical principals underlying clinical trials. Good awareness of, and familiarity with CDISC requirements. Good organizational/time management skills. What we offer: Mentorship and training to develop your skills in the clinical trials industry. The chance to be part of an effective, dynamic, friendly, and supportive team. Work with new and exciting technologies. Development opportunities. For more information about HiRO Company, please visit our page: https://harvestiro.com/ We also encourage you to follow our company page on Linkedin for the most up to date company news and job postings.