Senior Biostatistician - ROMANIA/UK/EU (CP07Ti617)

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 Biostatistician willing to be involved in all spectrum of activities, including acting as Lead on studies. This role can be home-based in Romania, Portugal, Spain, or the UK. 

Your core responsibilities:

·       To provide expert statistical input to Phase I-IV global clinical trials, including the design of clinical trials (protocol, sample size, randomisation, etc) and the production and review of analysis and reporting deliverables (including statistical analysis plans) on behalf of and/or in conjunction with Aixial Group 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 trials.

·       Responsible for the quality and timeliness of statistical deliverables.

·       As lead Statistician, to be primarily responsible for all statistical activities on allocated studies including planning and coordination of activities for assigned statistical team members.

This position is perfect for you if you have:

·       Minimum of a Masters (M.Sc.) or equivalent in Medical Statistics or minimum of a degree (or equivalent) in Statistics/Mathematics.

·       Minimum of 5 years of experience working for a CRO (including 1 to 2 years leading studies). 

·       Fluent in spoken and written English.

·       Excellent SAS programming skills. 

·       Experience of project managing (timelines and/or budgets) of statistical activities.

·       The ability to perform all duties as a project team member with no supervision.

·       The ability to perform all duties of lead team member on several concurrent studies 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.

·       Expert knowledge of clinical trial practices, procedures and methodologies.

·       Excellent organizational/time management skills.

·       Knowledge in developing statistical section of the study protocol and calculating sample size.  

·       Experience with Bayesian statistics (BOIN, CRM) is a plus. 

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.