Senior Statistician

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

📋 Description

• Serve as a communication bridge for project teams, clients, vendors, and internal staff regarding statistical inquiries.

• Perform statistical analyses for clinical trials, which includes interim analysis, final analysis, analyses for DSMBs/DMCs, and PK analysis.

• Create and assess study protocols, statistical analysis plans, and analysis dataset specifications in accordance with CDISC ADaM standards and other project-specific documentation.

• Evaluate statistical deliverables such as tables, figures, listings, and analysis datasets.

• Facilitate departmental induction courses and project-specific training for statisticians and SAS programmers.

• Prepare for and participate in both internal and external study audits relevant to Statistics.

• Engage in the preparation of follow-up activities for internal/external audits.

• Contribute to the development of standard operating procedures and other Quality Systems Documents (QSDs) related to the Biostatistics department's activities.

• Collaborate with Data Management on statistical inquiries concerning data issues.

• Take part in bid defense and kick-off meetings.

• Lead teams of SAS programmers and/or statisticians at the project level.

⛳️ Requirements

• MSc in Statistics or an equivalent qualification.

• In-depth knowledge and comprehension of statistical principles, concepts, methods, and standards utilized in clinical research.

• Proficient understanding of SAS programming.

• Comprehensive knowledge of CDISC ADaM standards.

• Advanced understanding of adaptive designs.

• Thorough knowledge of sample size calculations.

• Familiarity with relevant regulations and guidelines (e.g., FDA, EMA, ICH).

• Capability to apply advanced statistical techniques to support clinical research studies and to analyze, interpret, and draw conclusions from complex statistical data.

• Ability to consult with clinical investigators, interpret research needs, and devise statistical analysis strategies.

• Excellent presentation and communication skills.

🏝️ Benefits

• Employees have the flexibility to work remotely.