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Biostatisticians  - Belgium  

Company managed [?] Still accepting applications
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Posted on : 10 July 2017

Project Description

Job Purpose:
 Within the Bio statistics & Stat Programming team, bio statisticians provide statistical expertise and support in clinical studies in the development and life cycle of products.

 Key Responsibilities: 
  • Participate in the clinical development plan (trial designs, sample sizes, interim analysis, etc.). The position holder particularly, provide statistical, and scientific input into clinical development planning
  • Be responsible for the statistical designs of clinical studies, creating statistical sections for study synopses and protocols
  • Input in study set up (case report forms, database, randomization)
  • Explore new statistical approaches and methodologies through innovative and creative thinking
  • Propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans
  • Write and execute SAS programs to analyze the data and to report results creating tables and standard listings
  • Perform statistical analysis, run simulations and discuss with internal and external experts
  • Support scientific writers and clinicians to correctly interpret the statistical results and align them with the clinical report conclusions
  • Write the statistical sections of clinical study reports, statistical publications and prepare materials for publications and create statistical text for clinical study communications
  • Input in standard processes (review of Standard Operating Procedures, guidelines, definition of new processes needed)  

Basic qualifications: 
  • M.Sc. Degree, Ph.D. degree in Biostatistics or equivalent qualification
  • At least one year of experience as biostatistician in the Pharmaceutical field 
  • Understanding of applied statistical principles in the design and analysis of clinical studies.   

Preferred qualifications: 
  • Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis in either observational studies.
  • Proficiency in SAS (knowledge of other statistical software is an asset)
  • Good skill in written and spoken English
  • Ability to easily communicate with different functions: clinicians, scientists, data managers, scientific writers, commercials, etc. in an international, multi-cultural environment
  • Compliance with internal Standard Operating Procedures and regulatory guidelines   

What we offer 
  • You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).  
  • Each employee will be welcomed with a varied integration program.  
  • We invest considerable time and resources in training our staff (technical and non-technical courses).  
  • You will join a dynamic and international environment with enthusiastic and professional colleagues.  

 Who We are 
  • Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.  
  • Our ‘human’ approach to service provision is what differentiates us from our competitors. 
  • Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.  
  • We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better 
  • From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.