Sr/Principal Statistician

• Lead and support statistical activities across the full clinical study lifecycle, from protocol development through Clinical Study Report (CSR) completion.


• Develop Statistical Analysis Plans (SAPs), including mock tables, listings, and figures, ensuring clarity and alignment with study objectives and regulatory expectations.


• Contribute to protocol design, randomization strategies, and statistical input for clinical trial documentation and publications.


• Oversee and review statistical programming outputs, including analysis datasets, tables, listings, and figures for accuracy and compliance with specifications.


• Collaborate with sponsors and cross-functional teams to ensure robust study design and high-quality statistical deliverables.


• Coordinate and review the work of other biostatistics and statistical programming team members to ensure consistency and timely delivery.


• Conduct quality control and verification of study outputs, ensuring alignment with SAPs, protocols, and regulatory standards.


• Serve as a biostatistics representative on study teams, contributing to project planning, meetings, and cross-functional discussions.


• Monitor project timelines, manage multiple studies concurrently, and proactively escalate risks or delays when necessary.


• Support regulatory interactions, data monitoring committees, and integrated analyses when required.


• Contribute to business development activities, including proposal development, budgeting, and bid defense meetings.


• Mentor and coach junior biostatistics staff, supporting knowledge sharing and capability development.

Requirements

• Advanced degree (Master’s or PhD) in Statistics, Biostatistics, Mathematics, or a related quantitative field.


• Extensive experience as a statistician in clinical trials within the pharmaceutical, biotech, or CRO industry.


• Strong expertise in statistical methodology applied to clinical research, including study design, analysis planning, and interpretation of results.


• Experience preparing Statistical Analysis Plans (SAPs), clinical trial protocols, and regulatory submission documentation.


• Proficiency in SAS programming and familiarity with clinical trial data structures, analysis datasets, and reporting outputs.


• Solid understanding of regulatory guidelines (e.g., ICH) and Good Clinical Practice (GCP) requirements.


• Experience coordinating cross-functional teams and reviewing the work of statisticians and programmers.


• Strong organizational and time management skills with the ability to handle multiple complex studies simultaneously.


• Excellent communication skills with the ability to explain complex statistical concepts to non-statistical stakeholders.


• Experience contributing to regulatory submissions, DSMB/DMC activities, or integrated analyses is highly desirable.


• Leadership capabilities with mentoring or team coordination experience preferred.


• Fluency in English, both written and spoken.

Benefits

• Competitive compensation package aligned with senior-level expertise in clinical statistics.


• Flexible working arrangements across EMEA, including remote options.


• Opportunity to work on global clinical trials contributing to innovative drug development programs.


• Exposure to regulatory interactions and high-impact clinical research activities.


• Career development and progression opportunities within a global life sciences environment.


• Collaborative, science-driven culture with strong cross-functional teamwork.


• Involvement in high-profile studies spanning multiple therapeutic areas and geographies.


• Opportunity to mentor and influence the next generation of biostatistics professionals.