Senior Biostatistician

Senior Biostatistician

Alira Health

Remote, Europe

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 RESPONSIBILITIES​

• 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.

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