Biostatistician II

Role Summary

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.

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.

Benefits

• 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.

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About the Company

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.