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Senior Principal, Biostatistician

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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

THE SENIOR PRINCIPAL BIOSTATISTICIAN ROLE

The Senior 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 Senior 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
• Perform oversight of statistical documents to ensure high quality deliverables
• 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 11 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

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About Us

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

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