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Job Description Summary
Job Description
ROLE
The Senior Statistician provides statistical and methodological input necessary to plan, conduct, analyse and interpret results for studies in Phases I-IV and across studies for submission in a variety of therapeutic areas and in both medical device and drug settings.
KEY RESPONSABILITIES
Carries out tasks assigned within the timelines and the standards of quality
Provides supervisions on tasks carried out by biostatisticians
Preparation of Statistical Analysis Plans
Writing of the statistical methodology and results sections of reports
Provides statistical input to the design and review of Protocols and Case Report Forms
Prepares and performs trainings of other staff and clients on statistical methodology and statistical principles
Writes and reviews the statistical methodology and results sections of reports
Review of Statistical analysis (tables, figures and listings) and specifications of clinical trials
Performs sample size calculation
Writes Blind Review plans and reports
Writes and review statistical parts of scientific articles
Prepares and reviews Statistical Analysis Plans
Advises other staff and clients on statistical methodology and statistical principles
Participates and conducts Blind Review meeting
Supports the presentations to clients and manages the technical communications with client when assigned as lead statistician to a study
Create SAS programs for Datasets and TLFs validation
Prepares and performs training to internal/external staff on statistical methodology and statistical principles
Provides statistical input to the design and review of Protocols and Case Report Forms
Participates to DMC/DSMB meetings
Provides support to DMC/DSMB charter preparation
Reviews the specifications for analysis datasets
Conducts other activities as required
DESIRED QUALIFICATION & EXPERIENCE
Bachelor degree in Statistics
At least 3 years of experience in Biostatistics
TECHNICAL COMPETENCES & SOFT SKILLS
SAS Programming, Good
Broad Range of Statistical methodology skills, Very Good
ICH E9 Statistical Principles for Clinical Trials, Very Good
English, Good
MS Office Suite, Good
Professional
Trustworthy
Ability to effectively prioritize
Quality focused
Personable Attitude
Willingness to learn
Team Player
Effective Stress Management Techniques
Learning Agility
Ability to Manage Conflict
Problem Solving Skills
Effective Verbal Communication Skills
Commercial and Technical Writing Skills
Networking Skills
Languages
English
Education
Bachelor of Arts (BA): Statistics
Contract Type
Regular
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