This role involves leading intricate Real-World Evidence (RWE) studies as an individual contributor, providing statistical leadership across study design, analysis planning, and regulatory input. The position supports scientific publications, contributes to client strategies, and ensures high-quality statistical deliverables across multi-site projects in a remote European setting.
Responsibilities
- Lead sophisticated RWE studies or multi-protocol initiatives, coordinating statistical activities across geographically dispersed teams
- Provide statistical leadership and participate in key project meetings to guide study execution
- Take primary responsibility for creating detailed statistical analysis plans for complex observational studies
- Conduct senior-level reviews of statistical analysis plans developed by other team members
- Perform comprehensive statistical validation of Tables, Figures, and Listings before client submission
- Develop statistical components of study protocols under the guidance of senior consultants
- Share technical expertise through internal team meetings and external scientific conferences
- Support business development by participating in bid defense discussions with clients
- Serve as a subject matter expert by developing or reviewing standard operating procedures and contributing to strategic initiatives
Requirements
- Advanced degree in biostatistics, computer science, or a related quantitative field
- Minimum of five years of experience as a Lead Biostatistician in pharma, biotech, or CRO settings, with a focus on RWE studies
- Proficiency in statistical programming using SAS® for data analysis
- Demonstrated expertise in SAS procedures including non-parametric methods, linear and non-linear modeling, categorical data analysis, and survival analysis
- Hands-on experience with SDTM, ADaM datasets, and TFLs in real-world data contexts
- Ability to clearly explain statistical concepts to cross-functional teams and clients
- Solid understanding of observational study design and execution
- Experience in writing and reviewing statistical analysis plans, conducting analyses, and preparing study reports
- Strong organizational abilities, attention to detail, and a self-directed yet collaborative approach to work
Nice to Have
- Doctoral degree in a relevant field is preferred
Tech Stack
SAS, SDTM, ADaM, TFLs
Benefits
- Lead high-impact RWE studies that influence healthcare decisions
- Shape regulatory strategies for post-market product monitoring
- Contribute to influential scientific publications with global reach
- Be part of a culture driven by teamwork and excellence
- Work within a global network achieving meaningful health outcomes
- Grow professionally in an environment focused on innovation and patient impact
Work Arrangement
global — Europe — Remote (#LI-REMOTE)
Team
Consulting team dedicated to advancing Real-World Evidence (RWE) services
- Teamwork
- Excellence
- Innovation
- Commitment to delivering life-saving therapies
- Shared commitment to patients
- Breaking barriers
- Collaborative environment
