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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 #J-18808-Ljbffr