FSP Principal Biostatistician, Medical Affairs
IQVIA
Summary
The Principal Biostatistician is responsible for providing statistical analysis support for pharmaceutical research in Phase 2 and 3 clinical trials.
Job description
Job Responsibilities
- Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
- Author statistical analysis plans.
- Collaborate with Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations to provide statistical expertise.
- Contribute to publications and presentations.
- Provide guidance and supervision to programmers in planning and execution of analysis.
- Independently program or validate statistical outputs (tables, listings and figures) using SAS or R.
- Interpret study results and review reports of study results for accuracy.
- Support exploratory analyses.
Qualifications
- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
- MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
- At least 3 years in Phase 2/3 clinical trial experience.
- Demonstrated ability to work proactively and independently in a fast-paced environment.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary.
- Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
- Experience with CDISC, including SDTM, ADAM, CDASH.
Desired Experience
Contributing to peer-reviewed publications and presentations.
Requirements
- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience
- MS in Statistics, Biostatistics, or related field with 7+ years of industry experience
- At least 3 years in Phase 2/3 clinical trial experience
- Demonstrated ability to work proactively and independently in a fast-paced environment
- Able to effectively communicate ideas and manage programmers constructively
- Ability to use R or SAS for efficacy and safety analyses and validate data derivations
- Understanding of ICH GCP, ICH E9 and general industry practices
- Experience with CDISC, including SDTM, ADAM, CDASH
Benefits
- Home-based remote work
- Work/life balance
- Flexible schedules
- Technical training
- Tailored development curriculum
- Job stability
- Long-term engagements
- Re-deployment opportunities
- Regulatory submissions experience
- Fast-paced environment
Company overview
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Headquartered in Durham, North Carolina, the company operates in over 100 countries with approximately 86,000 employees worldwide. IQVIA specializes in creating intelligent connections across all aspects of healthcare through its proprietary IQVIA Connected Intelligence platform, which combines analytics, transformative technology, big data resources, and extensive domain expertise. The company's comprehensive portfolio includes clinical trial management, real-world evidence generation, commercial insights, and regulatory compliance services. IQVIA serves a diverse client base including pharmaceutical manufacturers, biotechnology companies, medical device firms, government agencies, and healthcare providers. With its Healthcare-grade AI capabilities and extensive global data assets, IQVIA accelerates the development and commercialization of innovative medical treatments while improving healthcare outcomes for patients globally. The company is publicly traded on the New York Stock Exchange under the ticker symbol IQV.