Senior Statistician

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

📋 Description

• Contribute to statistical efforts associated with global clinical trials.

• Collaborate closely with international teams of statisticians, programmers, and data managers, serving as the biostatistics project lead.

• Serve as the primary communication channel for project teams, clients, vendors, and internal teams regarding statistical inquiries.

• Perform statistical analyses for clinical trials, including interim, final, DSMB/DMC, and PK analyses.

• Develop and review study protocols, statistical analysis plans, ADaM analysis dataset specifications, and other project-specific documentation.

• Review statistical outputs, such as tables, figures, listings, and analysis datasets.

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

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

• Engage in follow-up actions for both internal and external audits.

• Contribute to the development of biostatistics standard operating procedures and Quality Systems Documents.

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

• Participate in bid defense and kick-off meetings.

• Lead project-level teams consisting of SAS programmers and/or statisticians.

⛳️ Requirements

• MSc in Statistics or a related field.

• In-depth understanding of statistical principles, concepts, methods, and standards applicable in clinical research.

• Proficient in SAS programming.

• Comprehensive knowledge of the CDISC ADaM standard.

• Advanced understanding of adaptive designs.

• Expertise in sample size calculations.

• Familiarity with pertinent regulations and guidelines, including FDA, EMA, and ICH.

• Capability to apply advanced statistical techniques in clinical research studies.

• Skill in analyzing, interpreting, and deriving conclusions from complex statistical data.

• Ability to consult with clinical investigators, interpret research requirements, and establish statistical analysis strategies.

• Excellent presentation and communication abilities.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and continuing education.

• Flexible working arrangements and a supportive work environment.