FSP Principal Biostatistician, Study Powering and Design
IQVIA
Summary
The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients.
Job description
Job Responsibilities
- Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
- Perform sample size and power calculations for optimizing study design.
- Author statistical analysis plans.
- Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
- Author or review analysis dataset and TLF specifications.
- Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF).
- Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
- Interpret study results and review reports of study results for accuracy.
- Support exploratory analyses.
- Participate in IND or NDA activities.
- Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
- Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of Clinical Safety).
Qualifications (Required)
- PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
- MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
- At least 2 years in Phase 2/3 clinical trial experience.
- At least 3 years of experience in supporting simulations, sample size and power calculations.
- Demonstrated ability to work pro-actively and independently.
- Able to effectively communicate statistical ideas and collaborate with cross-functional teams.
- Ability to efficiently use R or SAS to perform analyses.
- Support of various regulatory submissions.
- Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
- Experience in validation/programming of ADAM and TLF.
- Experience with CDISC, including SDTM, ADAM, CDASH.
- Solid understanding of estimands and multiple imputation methods.
Desired Experience
- Supporting written communications with regulators.
- 1+ years of experience with immunology therapeutic area.
- Bayesian methods.
Requirements
- PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
- MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
- At least 2 years in Phase 2/3 clinical trial experience.
- At least 3 years of experience in supporting simulations, sample size and power calculations.
- Demonstrated ability to work pro-actively and independently.
- Able to effectively communicate statistical ideas and collaborate with cross-functional teams.
- Ability to efficiently use R or SAS to perform analyses.
- Support of various regulatory submissions.
- Understanding of relevant FDA guidance, ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
- Experience in validation/programming of ADAM and TLF.
- Experience with CDISC, including SDTM, ADAM, CDASH.
- Solid understanding of estimands and multiple imputation methods.
- Supporting written communications with regulators.
- 1+ years of experience with immunology therapeutic area.
- Bayesian methods.
Benefits
- Remote working opportunities
- Work/life balance
- Flexible schedules
- Technical training
- Tailored development curriculum
- Career trajectory
- Job stability
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.