Principal Biostatistician

IQVIA

Remote

The Principal Statistician will be responsible for developing and maintaining standard statistical requirements in data analysis tools and templates, ensuring compliance with industry standards and health authority regulations. These requirements will be aligned with therapeutic area needs and study design considerations.

Key Responsibilities:

Develop and maintain standard statistical requirements, including text, definitions, and analysis requirements for Protocols and Statistical Analysis Plans.
Create standard tables, listings, and graph mock displays with detailed analysis requirements and rules in Data Presentation Specifications.
Maintain data analysis standards at a master level to meet scientific or operational requirements, ensuring formal change management control and versioning.
Govern changes to standards, maintaining multiple versions to align with clinical trials and drug development programs.
Support the clinical data standards team and standards implementation leads to ensure consistent adoption of standards in studies.
Expertise in experimental design, modeling, analysis planning, execution, interpretation, and statistical communications support.
Produce clear, concise, well-organized, and error-free analysis programs and statistical reporting content.
Establish and maintain effective relationships with internal and external customers.

Educational and Experience Requirements:

Master’s or PhD Degree in Statistics.
Expertise in SAS or R programming.
Working knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., ADaM).
Relevant operational experience in analysis standards is preferred.
Experience in multiple therapeutic areas (e.g., Oncology, Cardiovascular, Immunology, Medical Devices, Neuroscience) is preferred.
Ability to work independently with minimal oversight.

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