Early Development Clinical Statistician – Belgium
*Home working possible, with main presence in the office near Brussels
*Contract position until 2019 end, scope for extension
Our client, a global biopharmaceutical leader, is looking to add to their highly skilled Statistical Sciences team in Berkshire with a contractor for 12 months. This company transform the lives of people living with severe diseases, particularly in the areas of the central nervous system and immunology. As the world moves towards tailored medicines and treatment, this organisation is at the forefront of translational medicine and target discovery.
*Acts as trial statistician for one or more clinical studies within a clinical program or across multiple clinical programs.
*Works very closely with other statisticians and Project Lead Statistician, and the partner (CRO) lead biostatistician.
*Participates in the study concept, protocol development and biometric activities until clinical study report.
*Gives input into the study design, clinical pharmacology (PK/PD), efficacy and safety parameters and the planned statistical analyses.
*Oversight of partner activities for specific early phase studies
*Communicates and coordinates all statistical activities with external partner biostatisticians.
*Participates in data review/evaluation meetings and other study-related meetings and activities, reviews tables, figures, listings and perform any ad-hoc exploratory analysis.
*Reviews the clinical study report and provides input on interpretation of results by attending the Results Interpretation Meeting.
*Understands the regulatory requirements related to design and analysis of studies.
*Adheres to the company SOPs and working procedures.
*3-5 years in biostatistics within the biotechnology and/or pharmaceutical industry
*Experience in all phases of clinical studies, with particular experiences in Phase I – II (early phases studies, PK/PD, Proof of Concept and special population studies). Sound knowledge of the ICH guidelines. Understanding of the regulatory requirements from other health authorities
*Good knowledge of statistical methodology (including Bayesian statistics) and experience in analysis of pharmacokinetics / pharmacodynamics data
*Experience in Data mining activities to support Clinical Development Plans and simulations needed for statistical input into novel study designs
It would be great to hear from you if you are interested in a new contract position. The hourly rate will be competitive and we are keen for someone to start in the role ASAP. Please apply to this advert with your CV or contact Jade on +44 121 616 3472 for more information and an informal discussion.
Keywords: Early Development Clinical Statistician, Biopharmaceutical, Clinical Research, Statistical Sciences, SAS Programming, Belgium
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Job Reference: JP0304CS_1554282944
Broadcast As: 184
Salary Currency: GBP
Salary per: Annum
Job Type: Full Time
Job Term: Permanent
Job Industry: Pharmaceutical
Job Specialism: Biometrics
Recruitment Consultant: Jade Page