Principal Biostatistician, FSP - Permanent Homebased (m/w/d)
IQVIA
Principal Biostatistician, FSP - Permanent Homebased (m/w/d)
Principal Biostatistician needed to serve as statistical lead for late-phase clinical trials, providing scientific oversight and hands-on statistical support. Requires advanced degree in Biostatistics or Statistics, proven independent study statistician experience in Phase II/III trials, and proficiency in SAS. Permanent homebased position with IQVIA.
Principal Biostatistician, FSP - Permanent Homebased (m/w/d)
Principal Biostatistician needed to serve as statistical lead for late-phase clinical trials, providing scientific oversight and hands-on statistical support. Requires advanced degree in Biostatistics or Statistics, proven independent study statistician experience in Phase II/III trials, and proficiency in SAS. Permanent homebased position with IQVIA.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- Serve as the primary statistical lead and main point of contact on the Clinical Trial Team (CTT), representing Biostatistics with confidence and professionalism.
- Work independently to support clinical teams, providing proactive statistical guidance throughout the study lifecycle.
- Lead statistical strategy discussions, including endpoint definitions, analysis methods, risk mitigation, and regulatory expectations.
- Independently author Statistical Analysis Plans (SAPs), including drafting in collaboration with cross-functional partners, pharma statisticians, or from finalized protocols.
- Implement non-standard or advanced statistical methodologies.
- Perform or oversee statistical analyses, ensuring scientific rigor and regulatory compliance.
- Conduct sample size calculations using SAS or R, and justify design assumptions when engaging with clinical leadership.
- Work closely with statistical programmers, providing clear direction, reviewing outputs, and ensuring alignment between the SAP and programming deliverables.
- Contribute hands-on with SAS programming, including working with clinical datasets and performing analyses when needed.
- Actively participate in CTT meetings, offering statistical expertise and driving alignment across clinical, programming, data management, and medical writing partners.
- Proactively communicate with team members to anticipate needs, address issues, and ensure clarity on statistical approaches.
- Provide clear, influential explanations of statistical concepts to non-statistical stakeholders.