Principal Statistician

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

📋 Description

• Contribute to statistical initiatives associated with global clinical trials.

• Collaborate closely with international teams consisting of statisticians, programmers, and data managers.

• Serve as a communication link for project teams, clients, vendors, and internal teams on statistical inquiries.

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

• Create and review study protocols, statistical analysis plans, and analysis dataset specifications in line with CDISC ADaM, along with other project-specific documents.

• Evaluate statistical deliverables, which include tables, figures, listings, and analysis datasets.

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

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

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

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

• Coordinate 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.

• Act as the biostatistics project lead when necessary.

⛳️ Requirements

• MSc in Statistics or an equivalent qualification.

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

• Proficient knowledge and understanding of SAS programming.

• Comprehensive knowledge and understanding of the CDISC ADaM standard.

• Advanced understanding of adaptive designs.

• Thorough knowledge and understanding of sample size calculations.

• In-depth knowledge of relevant regulations and guidelines, including FDA, EMA, and ICH.

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

• Proficient in analyzing, interpreting, and drawing conclusions from complex statistical data.

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

• Strong presentation and communication skills.

🏝️ Benefits

• Comprehensive health insurance and wellness programs.

• Opportunities for professional development and training.

• Flexible work arrangements to promote work-life balance.

• Collaborative and supportive work environment.