Senior Statistician

About the Company

Founded in 1995, PSI CRO is a dynamic global organization comprising over 2,700 passionate professionals. We are committed to medical science innovation, improving lives by facilitating access to new medicines globally.

Role Overview and Responsibilities

As a Senior Statistician, you will take ownership of all biostatistics activities within clinical trials, acting as the lead project statistician. Your role involves active collaboration with project teams, clients, and external vendors to address statistical inquiries.

• Lead and manage statistical assignments related to clinical trials ensuring precise and accurate deliverables.
• Engage with various stakeholders including clients and project teams for statistical clarifications.
• Design and critically review statistical protocol sections, including determining appropriate sample sizes.
• Create comprehensive statistical analysis plans tailored to clinical research needs.
• Design and document analysis data structures, specifically SAS analysis datasets.
• Define SAS programming needs and specifications.
• Implement SAS programming and conduct program validation steps.
• Oversee review and quality control of statistical outputs including tables, listings, and figures.
• Conduct statistical analyses and clearly communicate the results in reports.
• Provide expert consultation on experimental design and statistical methodologies geared towards drug safety and efficacy assessment.
• Liaise with data management teams regarding statistical queries, ensuring organized data transfers between departments.
• Participate actively in key project meetings such as bid defenses and project kick-offs.
• Offer training and development for junior statisticians and SAS programmers.
• Prepare and present data at investigators’ meetings effectively.
• Address audit findings promptly, following up and ensuring successful resolution.

Qualifications and Skills

• Master’s degree in Statistics or a closely related discipline.
• Deep expertise in statistical principles, methodologies, and standards applicable to clinical research.
• Skillful application of advanced statistical techniques for clinical study support, including adept interpretation of complex data.
• Ability to consult with clinical investigators and derive appropriate statistical analysis strategies from research requirements.
• Proficient knowledge of SAS programming including expertise in CDISC ADaM standards.
• Familiarity with regulatory guidelines and standards such as FDA, EMA, and ICH.
• Fluency in English to communicate effectively across multinational teams.

Additional Information

PSI CRO aims to be recognized as the leading Contract Research Organization worldwide based on feedback from employees, clients, research sites, and vendors. Our recruitment approach is transparent and supportive, ensuring guidance throughout the hiring process.