Senior Biostatistician

October 21

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Alira Health

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Nuclear medicine • Rare disease • Lupus • Myasthenia gravis • Robotics

501 - 1000

💰 $58M Venture Round on 2023-01

Description

• 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. • 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 • Participates to DMC/DSMB meetings • Provides support to DMC/DSMB charter preparation • Reviews the specifications for analysis datasets • Conducts other activities as required

Requirements

• Bachelor degree in Statistics • At least 3 years of experience in Biostatistics • 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

Benefits

• professional development • global travel • flexible work programs