Principal Biostatistician at Catalyst Clinical Research in Durham, NC

Position Description:

Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies. Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology. Assist in developing, maintaining, and producing statistical programs and specifications used in creating analysis datasets, tables, listings, and figures. Manage and/or mentor junior level

biostatistics staff.

Position Qualification Requirements:

Education:

· Master’s degree, equivalent, or higher in biostatistics or a related field

· A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience

listed below

Experience:

· A minimum of 7+ years of relevant work experience

· Capable of conducting exploratory statistical analyses using statistical software packages

· Knowledge of CDISC submission and integrated safety and efficacy summary

· Previous experience in a pharmaceutical research or CRO setting required/preferred

Required Skills:

· Excellent verbal, written, and interpersonal skills

· Knowledge of clinical trial study design

· Able to work independently on multiple, concurrent projects

· Can attend study team meetings as needed

Position Responsibilities/ Accountabilities:

· Apply knowledge of basic and complex statistical design, analysis, and programming techniques

· Efficiently and effectively coordinate statistical activities for multiple projects simultaneously

· Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies

· Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations

· Maintain a professional working relationship with sponsors, collaborating associates, and vendors

· Represent department and company in a multi-disciplinary setting, including project team meetings and client meetings/presentations

· Effective oral and written communication of statistical concepts and results

· Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology

· Assist in developing, maintaining, and producing statistical programs and specifications used in creating analysis datasets, tables, listings, and figures

· Ensure the quality and integrity of data analysis and reporting

· Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate

· Actively monitor project budgets and help staff identify resource or scope of work changes

· Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management

· Attend related continuing education programs, professional meetings, and other career development activities sponsored

· Perform all other related duties as assigned

Working Conditions:

General office working conditions apply. Employee may be office or home based.

Frequent travel for meetings or training activities may be required.