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 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.

Key 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

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

We also encourage you to follow our company page on Linkedin for the most up to date company news and job postings.

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