Statistical Programmer III / Senior Statistical Programmer

Role Summary

We are currently looking for two enthusiastic and talented Statistical Programmers III , willing to be involved in all spectrums of activities, including acting as Lead on studies. This role works cross-functionally with internal departments and with external parties as well.

This role is home-based in Romania.

Responsibilities

• Creation and QC of study specifications for SDTM datasets, and statistical programming and QC of SDTM datasets for Phase I-IV trials.
• Creation and QC of study specifications for ADaM datasets, and statistical programming and QC of ADaM datasets for Phase I-IV trials.
• Statistical programming and QC of tables, listings and figures for Phase I-IV trials.
• Responsible for the quality and timeliness of assigned statistical deliverables.
• As Lead Statistical Programmer, primarily responsible for all statistical programming activities on assigned studies including planning and coordination of activities for assigned statistical programming team members.
• Active participation in improvements to departmental processes and procedures. (Senior Statistical Programmer)
• Provide mentoring within the Statistical Programming team. (Senior Statistical Programmer)
• Qualifications and attributes
• BSc/BA or equivalent in computer science, mathematics, statistics, life sciences or related field(s).
• Minimum of 4-5 years of experience working for a CRO
• Minimum of 5-6 years of experience working for a CRO (Senior Statistical Programmer)
• Excellent SAS programming skills (BASE, MACRO, GRAPH).
• Excellent knowledge of CDISC standards.
• Experience in statistical programming initiatives, and development of processes.
• Knowledge and experience in database design and structures.
• The ability to perform all duties as a statistical programming project team member with no supervision.
• The ability to perform all duties of Lead Statistical Programmer on several concurrent studies without supervision.
• Very good knowledge of clinical trial practices, procedures, and methodologies.
• Expert knowledge of clinical trial practices, procedures, and methodologies. (Senior Statistical Programmer)
• Strong oral and written communication skills.
• Excellent organizational/time management skills.
• An excellent investigative and meticulous approach to all activities and tasks

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.