Senior Statistician

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Oversee all biostatistical activities related to clinical trials as the lead project statistician.

• Engage with project teams, clients, and vendors to address statistical inquiries.

• Create and evaluate statistical sections of protocols, including sample size calculations.

• Formulate statistical analysis plans.

• Design and document analysis database structures (e.g., SAS analysis data set structures).

• Establish SAS program requirements and specifications.

• Conduct SAS programming and program validation.

• Review and ensure quality control of statistical deliverables (tables, listings, figures, etc.).

• Execute statistical analyses and report findings.

• Provide consultation on experimental design, statistical methods, and strategies for evaluating the safety and efficacy of drug products.

• Collaborate with Data Management on statistical inquiries related to data issues.

• Participate in bid defense meetings and project kick-off meetings.

• Mentor statisticians and SAS programmers.

• Prepare and present at investigators' meetings.

• Address findings and recommendations from audits.

⛳️ Requirements

• Master's degree in Statistics or a related field.

• Extensive knowledge and understanding of statistical principles, concepts, methods, and standards applicable in clinical research.

• Proficiency in applying a variety of advanced statistical techniques to support clinical research studies.

• Capability to consult with clinical investigators, interpret research requirements, and devise statistical analysis strategies.

• In-depth knowledge and understanding of SAS programming.

• Strong familiarity with the CDISC ADaM standard.

• Awareness of pertinent regulations and guidelines (e.g., FDA, EMA, ICH).

• Proficient in English communication.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.

• Opportunities for professional development.