Prinicipal Biostatistician

Location: Mexico Argentina or Brazil (Remote must be available to work Eastern or Central U.S. time zones)

We are seeking an experienced Principal Statistician to join our BIOS team for one of our FSP clients. This advanced-level position requires strong expertise in biostatistics and programming with a focus on clinical development in the pharmaceutical or biotech industry.

Key Responsibilities

• Author QC and implement Statistical Analysis Plans (SAPs) with minimal oversight

• Develop and validate SAS and/or R programs for tables listings and figures (TLFs) including reusable macros

• Perform QC/peer review and validation of statistical programs

• Produce statistical study reports and communicate results to clinical and cross-functional teams

• Review and contribute to statistical sections of study protocols

• Ensure compliance with CDISC SDTM and ADaM standards

Must Have

• Minimum 5 years of experience in biostatistics/statistics with substantial experience in pharmaceutical or biotech clinical development

• Strong programming skills in SAS and/or R

• Expertise in QC and validation processes

• Solid understanding of clinical trial design and analysis methods

Nice to Have

• PhD in Biostatistics or Statistics

• Experience in CNS therapeutic area

• Knowledge of adaptive designs and real-world evidence analyses

• Excellent communication skills

Education & Experience

• PhD: Minimum 3 years of relevant experience

• Masters: Minimum 5 years of relevant experience

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