The Principal Biostatistician will serve as the statistical lead for clinical studies, providing scientific oversight, strategic guidance, and hands‑on statistical support across late‑phase clinical trials. This role requires a highly experienced biostatistician capable of working independently, representing the Biostatistics function within cross‑functional teams, and delivering high‑quality statistical input throughout study design, execution, and analysis.
Key Responsibilities
Statistical Leadership & Study Support
- 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.
Statistical Analysis & Methodology
- 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, such as:
- Complex time‑to‑event analyses
- MMRM and other longitudinal models
- Methods aligned with estimands, including deep understanding of competing policies, assumptions, and analytical implications
- 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.
Programming Collaboration
- 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.
- Experience with R, CRM systems, or advanced tools is considered an asset.
Cross‑Functional Engagement
- 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.
Qualifications & Experience
- Advanced degree in Biostatistics, Statistics, or a related field (PhD preferred; Master’s accepted with significant experience).
- Proven experience working independently as a study statistician in late-phase (Phase II/III) clinical trials.
- Experience in pharmaceutical industry strongly preferred; CRO experience is a plus.
- Hands‑on expertise with clinical outcomes studies, including cardiovascular events, symptomatic endpoints, and quality‑of‑life measures.
- Demonstrated ability to implement complex statistical methods and guide cross‑functional teams through analytical decision‑making.
- Proficiency in SAS; working knowledge of R is advantageous.
- Experience with regulatory submissions and interaction with health authorities is a plus.
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 https://jobs.iqvia.com
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.
