Job Description

The Department of Neurology is seeking a Sr. Biostatistician who is responsible for data management and analysis of multicenter clinical trials. The Sr. Biostatistician will supervise research data analysts and work with principal investigators to analyze and manage data from studies.

Specific Duties & Responsibilities

• Work with a multidisciplinary group on clinical trials and other longitudinal studies.
• Collaborate with investigators on research projects with primary responsibility for analysis and presentation of project data.
• Provide integration and analysis of biodata from multiple sources.
• Provide expertise in statistical design, data management, and data analysis.
• Contribute to the development and application of statistical methods to advance scientific goals of various projects.
• Serve as lead Biostatistician with investigators to develop objectives, design sampling, randomization, and statistical analysis plans to achieve study objectives.
• Design and perform appropriate methodologic procedures for statistical analysis, overall descriptive statistics, exploratory data analyses, including graphs, schematic summaries, and necessary transformations and confirmatory data analyses, including statistical tests and/or modeling.
• Design, implement, and manage computerized systems for analysis of complex research projects to prepare scientific presentations related to study results.
• Perform sample size and power calculations, generate randomization schema, and prepare statistical sections for research protocols and manuscripts.
• Participate in regularly scheduled meetings with investigators and team that require statistical input.
• Design tables and statistical procedures for specific research studies.
• Write statistical design, methods, and analysis for manuscripts and research proposals.
• Analyze data and prepare tables for interim and final reports.
• Develop and apply new statistical methodologies.
• Ensure data integrity and compliance with security policies governed by HIPAA and the Johns Hopkins IRB.
• Oversight of one or more professional team members and project milestones.
• Prepare progress reports and present to leadership.
• Other duties as assigned.

In addition to the duties described above

• Lead development and writing of statistical analysis plans.
• Lead development of specifications for derived datasets used to generate data summaries and statistical analysis.
• Develop table, listings, and figures (TLFs) shells in preparation for analysis programming.
• Oversee production of TLFs to support safety reviews (including DSMBs), publications, and ongoing study reporting.
• Program additional ad hoc requests to support clinical trial conduct and reporting including sample size calculations and data missingess.
• Identify data discrepancies and collaborate with trial leadership to resolve.
• Collaborate with project management to develop analytic timelines and deliverables.

Minimum Qualifications

• Master's Degree in Biostatistics, Epidemiology, or related quantitative field.

• Three years of related experience.

• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

Technical Skills & Expected Level of Proficiency

• Analytic Methodological Development - Intermediate
• Clinical Trial Design & Data Management - Intermediate
• Data Integration - Intermediate
• Interpersonal Skills General - Intermediate
• Project Management - Intermediate
• Regulatory Compliance - Intermediate
• Scientific Communication - Intermediate
• Statistical Methods - Intermediate
• Statistical Programming - Intermediate

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

Classified Title: Sr. Biostatistician
Role/Level/Range: ACRP/04/ME
Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine

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