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Job Description Summary
The Principal Biostatistician takes responsibility of the projects they are assigned to, meeting the timelines and the standards of quality agreed for deliverables and keeps good communication both externally with the clients for technical aspects and internally with the team and the project managerThe Principal Biostatistician prepares the Statistical Analysis Plans, writes the statistical methodology and the results sections of reports, provides statistical input to the design and review of Protocols and Case Report Forms and prepares and performs trainings for other staff and clients on statistical methodology and statistical principles.
Job Description
THE PRINCIPAL BIOSTATISTICIAN ROLE
The Principal Biostatistician takes responsibility of the projects they are assigned to, meeting the timelines and the standards of quality agreed for deliverables and keeps good communication both externally with the clients for technical aspects and internally with the team and the project manager
The Principal Biostatistician prepares the Statistical Analysis Plans, writes the statistical methodology and the results sections of reports, provides statistical input to the design and review of Protocols and Case Report Forms and prepares and performs trainings for other staff and clients on statistical methodology and statistical principles.
ESSENTIAL JOB FUNCTIONS*
- Prepares and reviews Statistical Analysis Plans and specifications
- Writes and reviews the statistical methodology and results sections of reports.
- Performs sample size calculations.
- Review of Statistical analysis (tables, figures and listings) of clinical trials.
- Provides support to DMC/DSMB charter preparation
- Participates to DMC/DSMB meeting as independent statistician
- Provides statistical input to the design and review of Protocols and Case Report Forms.
- Writes Blind Review plans and reports.
- Participates and conducts Blind Review meeting.
- Prepares and performs training to internal/external staff on statistical methodology and statistical principles
- Writes and reviews statistical parts of scientific articles
- Creates SAS and/or R programs for Datasets and TLFs validation
- Reviews the specifications for analysis datasets
- Manages the technical communications with client
- Provides pastoral care to biostatisticians they are assigned to
- Advises other staff and clients on statistical methodology and statistical principles
- Supports Quality Assurance in internal and external audits
- Supports the Director of Biostatistics in reviewing baseline estimations and Project Plans
- Supports in reviewing budget proposals
- Conducts other activities as required
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
- Master’s degree in Statistics
- At least 7 years of experience in Biostatistics
- SAS Programming, Good
- R Programming, Basic/Good
- Broad Range of Statistical Methodology skills, Very Good
- ICH E9 Statistical Principles for Clinical Trials, Very Good
- English, Very 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
- Analytical thinking
- Resilient
- Ability to Influence and motivate
- Ability to manage difficult conversations
- Innovative
- Ability to Provide Constructive Feedback
- Excellent Presentation Skills
- Commercial awareness
- Ability to recognize and develop talent
Languages
English
Education
Bachelor of Science (BS): Statistics
Contract Type
Regular
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