Principal Biostatistician , Medical Affairs (FSP -Permanent Homebased)
IQVIA Madrid
Experteer Overview
In this role you will serve as principal biostatistician, directing statistical planning, analysis and reporting to support pharmaceutical development and regulatory submissions. You will act as a resource across the biostatistics department, ensuring scientific integrity and regulatory compliance in clinical trial analysis.As lead statistician on major projects, you will shape protocols, analysis plans, and integrated reports, and respond to regulators. You will collaborate with cross-functional teams and drive risk management, data standards, and quality control.
This position offers high-impact opportunities to influence submissions and scientific outcomes.
Compensaciones / Beneficios- Serve as a biostatistical consultant for department and other Biostatistics groups
- Represent sponsors in regulatory meetings and may participate on a Data and Safety Monitoring Committee
- Lead biostatistical work on major projects, developing/reviewing protocols and analysis plans, and writing integrated reports
- Lead operational studies and contribute to methodological development for statistical standards and validation
- Mentor and share knowledge as SME; review statistical deliverables and data management deliverables
- Control lock/unblinding processes for the statistical team; participate in randomization QC and team activities
- Provide expert input on ADaM ADRG and metadata; perform senior biostatistical review (SBR)
- Perform quality control of sample size calculations for complex studies
- Identify and mitigate risks to project delivery and quality
- Masters or PhD in Biostatistics or related field with relevant life-sciences industry experience
- Expert in a broad range of complex statistical methods for Phase 2-3 trials
- Experience as statistical lead for regulatory submissions and eCTD support
- Strong knowledge of GCP/ICH guidelines and regulatory requirements
- Proficiency in SAS or R; knowledge of CDISC Data Standards
- Excellent communication and collaboration skills; proactive problem solving
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IQVIAMadrid
Experteer Overview
In this role you will serve as the statistical lead for late‑phase clinical trials, guiding study design, analysis, and regulatory interactions. You will collaborate with cross‑functional teams to translate scientific questions...
IQVIAMadrid
Experteer Overview
In this role you will develop and QC NONMEM-ready PK/PD datasets from SDTM/ADaM sources, enabling robust pharmacometrics analyses. You will work with cross-functional teams to ensure data quality from unclean to post-lock stages...
CapgeminiMadrid
potential home-based flexibility (1 day per week)
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• Collaborate with...