Job Description

Location: Timișoara,Timiș,Romania

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

We are currently looking for an enthusiastic and talented Senior Statistical Programmer. This role can be home-based in EU where we have the ability to hire or in the UK.

Your core 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.
• Provide mentoring within the Statistical Programming team.

This position is perfect for you if you have:

• BSc/BA or equivalent in computer science, mathematics, statistics, life sciences or related field(s).
• Excellent SAS programming skills (BASE, MACRO, GRAPH).
• Excellent knowledge of CDISC standards.
• Statistical Programming experience within a CRO Pharmaceutical/Healthcare/Biotechnology industries.
• 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 with minimal supervision.
• Expert knowledge of clinical trial practices, procedures and methodologies.
• 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:

• Opportunity to be part of an innovative organization and work with exciting technologies.
• Mentoring and training to develop your skills in the clinical trials industry.
• The chance to be part of an effective, friendly and supportive team.
• Competitive employment package.

For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.

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