Manages internal staff and outside consultants to effectively provide statistical project support to investigators and project teams. Acts as a subject matter expert in respective field, provides peer review of biostatistics work, and maintains statistical and analytical integrity of studies. Maintains department specific processes and implements strategies to increase department productivity and quality.
Provides oversight for bio-statistics personnel and statistical operations. Responsible for hiring of personnel, management of personnel matters, and conduct of performance evaluations. Develops, coaches, and mentors junior level bio-statisticians on applicable regulatory guidelines and statistical practices.
Manages resource allocation and development of business strategies related to bio-statistics. Maintains departmental and project budgets. Provides project management support to investigators and assists in the development of scope and timelines as it relates to bio-statistics.
Plays a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report and other documents, ensuring accurate and statistically valid deliverables. Provides final review of all statistical deliverables to ensure accuracy and integrity. Serves as project lead when applicable.
Develops and coordinates quality control procedures for bio-statistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific projects. Writes and contributes to standard operating procedures for bio-statistics. Makes recommendations for process improvement.
Represents the Bio-statistics function at leadership and management meetings, serves on key scientific committees, and advises research study teams on statistical issues. Interacts with internal and external collaborators, management, vendors, and consultants. May represent Aurora Research Institute externally on statistical matters at meetings with regulatory authorities and key opinion leaders.
Serves as an internal consultant for the department on bio statistical analysis tools and methods. Acts as primary liaison with data analytics to ensure data collection needs of the study team are met.
Performs human resources responsibilities for staff which include interviewing and selection of new employees, promotions, staff development, performance evaluations, compensation changes, resolution of employee concerns, corrective actions, terminations, and overall employee morale.
Develops and recommends operating and capital budgets and controls expenditures within approved budget objectives.
Responsible for understanding and adhering to the Aurora Health Care Code of Ethical Conduct and for ensuring that personal actions, and the actions of employees supervised, comply with the policies, regulations and laws applicable to Aurora's business.
Master's Degree in Statistics or related field.
Typically requires 5 years of experience in academic or industrial/health research as a senior bio-statistician in one of the following areas: cardiovascular, cancer, epidemiology, neuroscience, women's health, clinical informatics, bioinformatics or health economics. As well as previous experience leading technical teams and managing complex projects.
Knowledge, Skills & Abilities Required:
Demonstrated excellence in direct personnel management or evidence of leadership of teams and/or projects. Effective leadership and strategic management skills.
Advanced level knowledge of statistics/biostatics or related field preferably in areas of epidemiology or medical informatics.
Demonstrated expertise in clinical research methods and study design.
Ability to identify data-related issues, present problems, and implement solutions.
Ability to effectively communicate technical concepts clearly, concisely, and at the appropriate level so that it is understandable to the audience being addressed.
Project management abilities including analytical evaluation, delegation, organization, and resource management skills.
Must be proficient in the use of Microsoft Office (Excel, Access, PowerPoint and Word) or similar products.
Demonstrated proficiency of R, SAS, PASS, SPSS and other statistical programming and software.
Prior experience implementing analysis tools in research or corporate environment.
Must have excellent communication and presentation skills.
Physical Requirements and Working Conditions:
Must be able to operate all equipment essential to performing the job.
Exposed to normal office environment.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.
Employer will assist with relocation costs.
Additional Salary Information: Bonus Eligible
Internal Number: 174948
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