www.4clinics.com Waterloo : Biostatistician, Clinical Data Analyst

Name Of the Company : 4CLINICS
Company Location : Waterloo
Designation : Biostatistician, Clinical Data Analyst
Country : Belgium
Official Website : http://www.4clinics.com/en/careers.html

Biostatistician :
Job Biostatistics :
To provide statistical expertise in the design, planning, conduct, analysis and reporting of clinical studies. To ensure statistical validity and overall quality of deliverables.
Scope :
Statistical support for all studies analyzed on behalf of the sponsor by 4Clinics. Will have much direct contact with the client, both the statistical and clinical teams. Will work together with Clinical Data Managers, Clinical Data Analysts and Medical Writers to produce high quality results.
Key Responsabilities :
Define methodology of the study
Calculate sample size and writes statistical sections of the protocol
Write the Statistical Analysis Plan
Create counting rules to be included in the Data Dictionary Table (DDT)
Perform quality control of analysis datasets
Develop and maintain statistical programs as necessary to perform analyses, to prepare data displays and to verify data accuracy
Perform statistical analyses and interpret the results
Write sections of CSRs or publications as needed
Qualification :
Master’s Degree in Sciences preferably in Computer Science, Life Sciences or related fields with post-graduate degree in Statistics or Biostatistics.
Must have at least 5 years clinical trial experience to write protocols
Extensive SAS knowledge, other statistical software knowledge is a plus
Excellent communication skills in English, both written and verbal
Able to explain statistical concepts to non-statisticians
Good team player and flexible to work on diverse projects in various disease areas
Place :
The position can be based in Waterloo (Belgium) or Paris (France).

Safety Analyst :
Job Data Management/Safety :
The role is about providing support to research projects or product teams in reviewing, monitoring and managing clinical safety databases.
Responsibilities :
The successful candidate will work closely with the Sponsor and the Clinical Data Management department in order to perform all activities related to the Safety Data Management of clinical trials.
Perform ongoing systematic data compilation and initial review of safety information,
Perform regulatory evaluation and assign causality and labeledness as applicable,
Code cases using appropriate dictionary,
Search and input data in electronic databases,
Generate, track and resolve adverse event follow-up/ distribution correspondence,
Manage adverse events reports from initial case and generate periodic reports; and other ad hoc reports,
Prepare summary reports for internal and external use,
Insure quality control of inputted safety data.
Your Current Profile :
Bachelor’s Degree, Registered Nurse or Pharmacist / Registered Diploma or Associate Degree Nurse with preferred 3 years experience,
Knowledge of ICH/FDA regulations, guidelines affecting drug safety issues,
Ability to understand product labelling/literature,
Clinical knowledge to apply to adverse event data collection and assessment,
Computer proficiency,
Data analysis, synthesis, problem solving and time management skills,
Good communication skills in English, both written and verbal,
Good team player and flexible to work on diverse projects in various disease areas.
Place :
The position can be based in Waterloo (Belgium) or Paris (France).

Clinical Data Analyst :
Job Data Management/Safety
To provide technical support for clinical trials managed and analyzed by 4Clinics.
Job Purpose :
To provide technical support for clinical trials managed and analyzed by 4Clinics.
Scope :
Will work closely with the Clinical Data Management and Statistical departments in order to provide technical support for clinical trials. Could have some client contact, but this is not a major part of the job.
Key Responsibilities :
Setup the clinical database
Design the data entry screens
Create the annotated CRF
Design edit checks on raw data
Upload electronic data into the clinical db
Build on-line reports
Create data listings for manual checks
Create data listings from CRF data
Generating SAS copies of the DB
Writing programs for analysis datasets (ADs) based on the Statistical Analysis Plan
Creating programs for tables, figures and listings for the Clinical Study Report (CSR)
Performing QC of statistical programs
Create tables and figures based on the SAP
Qualifications :
Master’s Degree in Sciences with IT skills or Bachelor’s Degree in Computer Skills
Extensive knowledge of SQL
Extensive SAS knowledge, other statistical software knowledge is a plus
Good knowledge of data mining tools
Good communication skills in English, both written and verbal
Good team player and flexible to work on diverse projects in various disease areas

Contact us :
Drève Richelle 161
Bâtiment G
B-1410 Waterloo