Principal Biostatistician
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Job Location:
Buenos Aires - Argentina
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Location: Mexico Argentina or Brazil (Remote must be available to work Eastern or Central U.S. time zones)
100% home based role
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
PhD in Biostatistics or Statistics
English Advanced
Minimum 5 years of experience in biostatistics/statistics with substantial experience in pharmaceutical or biotech clinical development
CMC experience (Chemistry Manufacturing and Controls)
Strong experiences in end-to-end statistical support across the product lifecycle including analytical method development and validation formulation development and robustness and process development and validationaligned with regulatory standards such as FDA EMA ICH and USP
Strong programming skills in SAS and/or R
Solid knowledge of linear mixed models multivariate analysis design of experiments and Bayesian statistics is essential.
Proficiency in the R language is required with the development of automated reproducible workflows using R Markdown and Quarto to enhance regulatory submission readiness.
Expertise in QC and validation processes
Solid understanding of clinical trial design and analysis methods
Nice to Have
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
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
Staff IC
Key Skills
- Business Development
- Classroom Experience
- Dayforce
- Go
- Cloud Computing
- AWS
- Teaching
- Administrative Experience
- Leadership Experience
- negotiation
- SAS
- Data Analysis Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
